Document:

Exhibit

EXHIBIT 4.4

FORM OF SUBSIDIARY GUARANTY
THIS GUARANTY (this “Guaranty”) dated November [__], 2015 is made by the undersigned (each, a “Guarantor”), in favor of the holders from time to time of the Notes issued under the Note Purchase Agreement and any Supplement thereto, including each purchaser named in the Note Purchase Agreement and in any Supplement thereto, and their respective successors and assigns (collectively, the “Holders” and each individually, a “Holder”).
W I T N E S S E T H:

WHEREAS, TETRA TECHNOLOGIES, INC., a Delaware corporation (the “Company”), and the initial Holders have entered into a Note Purchase Agreement dated as of November 5, 2015 (the Note Purchase Agreement as amended, supplemented, restated or otherwise modified from time to time in accordance with its terms and in effect, the “Note Purchase Agreement”);
WHEREAS, pursuant to the Note Purchase Agreement, the Company has issued $125,000,000 principal amount of Series 2015 Notes;
WHEREAS, the Company directly or indirectly owns all or a substantial portion of the issued and outstanding Equity Interest of each Guarantor and, by virtue of such ownership and otherwise, such Guarantor will derive substantial benefits from the purchase by the Holders of the Company’s Notes;
WHEREAS, it is a condition precedent to the obligation of the Holders to purchase the Notes that each Guarantor shall have executed and delivered this Guaranty to the Holders and it is and will be a condition to the sale of Additional Notes that this Guaranty run in favor of the holders of such Additional Notes; and
WHEREAS, each Guarantor desires to execute and deliver this Guaranty to satisfy the conditions described in the preceding paragraph;
NOW, THEREFORE, in consideration of the premises and other benefits to each Guarantor and for other good and valuable consideration, the receipt and sufficiency of which are acknowledged, each Guarantor makes this Guaranty as follows:
SECTION 1.    Definitions.  Any capitalized terms not otherwise herein defined shall have the meanings attributed to them in the Note Purchase Agreement.
SECTION 2.    Guaranty.  Each Guarantor, jointly and severally with each other Guarantor, unconditionally and irrevocably guarantees to the Holders the due, prompt and complete payment by the Company of the principal of, make-whole amount, if any, other premium, if any, and interest on, and each other amount due under, the Notes or the Note Purchase Agreement and any Supplement thereto, when and as the same shall become due and payable (whether at stated maturity or by required or optional prepayment or by acceleration or otherwise) in accordance with the terms of the Notes, the Note Purchase Agreement and any Supplement thereto (the Notes, the Note Purchase Agreement and any Supplement being sometimes hereinafter collectively referred to as the “Applicable Note Documents” and the amounts payable by the Company under the Applicable Note Documents, and all other monetary obligations of the Company thereunder (including any attorneys’ fees and expenses), being sometimes collectively hereinafter referred to as the “Obligations”).  This Guaranty is a guaranty of payment and not just of collectibility and is in no way conditioned or contingent upon any attempt to collect from the Company or upon any other event, contingency or circumstance whatsoever.  If for any reason whatsoever the Company shall fail or be unable duly, punctually and fully to pay such amounts as and when the same shall become due and payable, each Guarantor, without demand, presentment, protest or notice of any kind, will forthwith pay or cause to be paid such amounts to the Holders under the terms of such Applicable Note Documents, in lawful money of the United States, at the place specified in the Note Purchase Agreement, or perform or comply with the same or cause the same to be performed or complied with, together with interest (to the extent provided for under such Applicable Note Documents) on any amount due and owing from the 

Company.  Each Guarantor, promptly after demand, will pay to the Holders the reasonable costs and expenses of collecting such amounts or otherwise enforcing this Guaranty, including, without limitation, the reasonable fees and expenses of counsel.  Notwithstanding the foregoing, the right of recovery against each Guarantor under this Guaranty is limited to the extent it is judicially determined with respect to any Guarantor that entering into this Guaranty would violate Section 548 of the United States Bankruptcy Code or any comparable provisions of any state law, in which case such Guarantor shall be liable under this Guaranty only for amounts aggregating up to the largest amount that would not render such Guarantor’s obligations hereunder subject to avoidance under Section 548 of the United States Bankruptcy Code or any comparable provisions of any state law.
SECTION 3.    Guarantor’s Obligations Unconditional.  The obligations of each Guarantor under this Guaranty shall be primary, absolute and unconditional obligations of each Guarantor, shall not be subject to any counterclaim, set-off, deduction, diminution, abatement, recoupment, suspension, deferment, reduction or defense based upon any claim each Guarantor or any other person may have against the Company or any other person, and to the full extent permitted by applicable law shall remain in full force and effect without regard to, and shall not be released, discharged or in any way affected by, any circumstance or condition whatsoever (whether or not each Guarantor or the Company shall have any knowledge or notice thereof), including:
(a)any termination, amendment or modification of or deletion from or addition or supplement to or other change in any of the Applicable Note Documents or any other instrument or agreement applicable to any of the parties to any of the Applicable Note Documents;

(b)any furnishing or acceptance of any security, or any release of any security, for the Obligations, or the failure of any security or the failure of any person to perfect any interest in any collateral;

(c)any failure, omission or delay on the part of the Company to conform or comply with any term of any of the Applicable Note Documents or any other instrument or agreement referred to in paragraph (a) above, including, without limitation, failure to give notice to any Guarantor of the occurrence of a “Default” or an “Event of Default” under any Applicable Note Document;

(d)any waiver of the payment, performance or observance of any of the obligations, conditions, covenants or agreements contained in any Applicable Note Document, or any other waiver, consent, extension, indulgence, compromise, settlement, release or other action or inaction under or in respect of any of the Applicable Note Documents or any other instrument or agreement referred to in paragraph (a) above or any obligation or liability of the Company, or any exercise or non-exercise of any right, remedy, power or privilege under or in respect of any such instrument or agreement or any such obligation or liability;

(e)any failure, omission or delay on the part of any of the Holders to enforce, assert or exercise any right, power or remedy conferred on such Holder in this Guaranty, or any such failure, omission or delay on the part of such Holder in connection with any Applicable Note Document, or any other action on the part of such Holder;

(f)any voluntary or involuntary bankruptcy, insolvency, reorganization, arrangement, readjustment, assignment for the benefit of creditors, composition, receivership, conservatorship, custodianship, liquidation, marshaling of assets and liabilities or similar proceedings with respect to the Company, any other Guarantor or to any other person or any of their respective properties or creditors, or any action taken by any trustee or receiver or by any court in any such proceeding;

(g)any discharge, termination, cancellation, frustration, irregularity, invalidity or unenforceability, in whole or in part, of any of the Applicable Note Documents or any other agreement or instrument referred to in paragraph (a) above or any term hereof;

(h)any merger or consolidation of the Company or any Guarantor into or with any other Person, or any sale, lease or transfer of any of the assets of the Company or any Guarantor to any other person;

(i)any change in the ownership of any shares of Capital Stock of the Company or any change in the corporate relationship between the Company and any Guarantor, or any termination of such relationship;

(j)any release or discharge, by operation of law, of any other Guarantor from the performance or observance of any obligation, covenant or agreement contained in this Guaranty; or

(k)any other occurrence, circumstance, happening or event whatsoever, whether similar or dissimilar to the foregoing, whether foreseen or unforeseen, and any other circumstance which might otherwise constitute a legal or equitable defense (other than the defense of payment) or discharge of the liabilities of a guarantor or surety or which might otherwise limit recourse against any Guarantor.

SECTION 4.    Full Recourse Obligations.  The obligations of each Guarantor set forth herein constitute the full recourse obligations of such Guarantor enforceable against it (subject to the last sentence of Section 2) to the full extent of all its assets and properties.
SECTION 5.    Waiver.  Each Guarantor unconditionally waives, to the extent permitted by applicable law, (a) notice of any of the matters referred to in Section 3, (b) notice to such Guarantor of the incurrence of any of the Obligations, notice to such Guarantor or the Company of any breach or default by such Guarantor or the Company with respect to any of the Obligations or any other notice that may be required, by statute, rule of law or otherwise, to preserve any rights of the Holders against such Guarantor, (c) presentment to or demand of payment from the Company or the Guarantor with respect to any amount due under any Applicable Note Document or protest for nonpayment or dishonor, (d) any right to the enforcement, assertion or exercise by any of the Holders of any right, power, privilege or remedy conferred in the Note Purchase Agreement or any other Applicable Note Document or otherwise, (e) any requirement of diligence on the part of any of the Holders, (f) any requirement to exhaust any remedies or to mitigate the damages resulting from any default under any Applicable Note Document, (g) any notice of any sale, transfer or other disposition by any of the Holders of any right, title to or interest in the Note Purchase Agreement or in any other Applicable Note Document and (h) any other circumstance whatsoever which might otherwise constitute a legal or equitable discharge, release (other than a release of such Guarantor herefrom pursuant to Section 1.2(b) of the Note Purchase Agreement) or defense of a guarantor or surety (other than the defense of payment) or which might otherwise limit recourse against such Guarantor.
SECTION 6.    Subrogation, Contribution, Reimbursement or Indemnity.  Until all Obligations have been indefeasibly paid in full, each Guarantor agrees not to take any action pursuant to any rights which may have arisen in connection with this Guaranty to be subrogated to any of the rights (whether contractual, under the United States Bankruptcy Code, as amended, including Section 509 thereof, under common law or otherwise) of any of the Holders against the Company or against any collateral security or guaranty or right of offset held by the Holders for the payment of the Obligations. Until all Obligations have been indefeasibly paid in full, each Guarantor agrees not to take any action pursuant to any contractual, common law, statutory or other rights of reimbursement, contribution, exoneration or indemnity (or any similar right) from or against the Company which may have arisen in connection with this Guaranty.  So long as any Obligations remain outstanding, if any amount shall be paid by or on behalf of the Company to any Guarantor on account of any of the rights waived in this Section 6, such amount shall be held by such Guarantor in trust, segregated from other funds of such Guarantor, and shall, forthwith upon receipt by such Guarantor, be turned over to the Holders (duly endorsed by such Guarantor to the Holders, if required), to be applied against the Obligations, whether matured or unmatured, in such order as the Holders may determine.  The provisions of this Section 6 shall survive the term of this Guaranty and the payment in full of the Obligations.
SECTION 7.    Effect of Bankruptcy Proceedings, etc.  This Guaranty shall continue to be effective or be automatically reinstated, as the case may be, if at any time payment, in whole or in part, of any of the sums due to any of the Holders pursuant to the terms of the Note Purchase Agreement or any other Applicable Note Document is rescinded or must otherwise be restored or returned by such Holder upon the insolvency, bankruptcy, dissolution, liquidation or reorganization of the Company or any other person, or upon or as a result of the appointment of a custodian, receiver, trustee or other officer with similar powers with respect to the Company or other person or any substantial part of its property, or otherwise, all as though such payment had not been made.  If an event permitting 

the acceleration of the maturity of the principal amount of the Notes shall at any time have occurred and be continuing, and such acceleration shall at such time be prevented by reason of the pendency against the Company or any other person of a case or proceeding under a bankruptcy or insolvency law, each Guarantor agrees that, for purposes of this Guaranty and its obligations hereunder, the maturity of the principal amount of the Notes and all other Obligations shall be deemed to have been accelerated with the same effect as if any Holder had accelerated the same in accordance with the terms of the Note Purchase Agreement or other Applicable Note Document, and such Guarantor shall forthwith pay such principal amount, make-whole amount, if any, other premium, if any, and interest thereon and any other amounts guaranteed hereunder without further notice or demand.
SECTION 8.    Term of Agreement.  This Guaranty and all guaranties, covenants and agreements of each Guarantor contained herein shall continue in full force and effect and shall not be discharged until such time as all of the Obligations shall be paid and performed in full and all of the agreements of such Guarantor hereunder shall be duly paid and performed in full; provided that each Guarantor shall be automatically and immediately released herefrom without any further act by any Person as provided in Section 1.2(b) of the Note Purchase Agreement.
SECTION 9.    Representations and Warranties.  Each Guarantor represents and warrants to each Holder that:
(a)such Guarantor is a corporation, limited partnership or limited liability company, as the case may be, duly organized, validly existing and in good standing under the laws of its jurisdiction of organization and has the corporate, limited partnership or limited liability company, as the case may be, power and authority to own and operate its property, to lease the property it operates as lessee and to conduct the business in which it is currently engaged;

(b)such Guarantor has the corporate, limited partnership or limited liability company, as the case may be, power and authority and the legal right to execute and deliver, and to perform its obligations under, this Guaranty, and has taken all necessary corporate, limited partnership or limited liability company, as the case may be, action to authorize its execution, delivery and performance of this Guaranty;

(c)this Guaranty constitutes a legal, valid and binding obligation of such Guarantor enforceable in accordance with its terms, except as enforceability may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, fraudulent transfer, moratorium or similar laws affecting the enforcement of creditors’ rights generally and by general equitable principles (regardless of whether such enforceability is considered in a proceeding in equity or at law);

(d)the execution, delivery and performance of this Guaranty will not violate any provision of any requirement of law or material contractual obligation of such Guarantor and will not result in or require the creation or imposition of any Lien on any of the properties, revenues or assets of such Guarantor pursuant to the provisions of any material contractual obligation of such Guarantor or any requirement of law;

(e)no consent or authorization of, filing with, or other act by or in respect of, any arbitrator or Governmental Authority is required as to such Guarantor in connection with the execution, delivery or performance of this Guaranty by such Guarantor or the validity or enforceability of this Guaranty;

(f)no litigation, investigation or proceeding of or before any arbitrator or Governmental Authority is pending or, to the knowledge of such Guarantor, threatened by or against such Guarantor or any of its properties or revenues (i) with respect to this Guaranty or any of the transactions contemplated hereby or (ii) which could reasonably be expected to have a Material Adverse Effect;

(g)the execution, delivery and performance of this Guaranty by such Guarantor will not violate any provision of any order, judgment, writ, award or decree of any court, arbitrator or Governmental Authority, domestic or foreign, applicable to such Guarantor or of the certificate or articles of incorporation, by-laws, certificate of formation, articles of organization or operating agreement, as applicable, of such Guarantor or of any securities issued by such Guarantor;

(h)after giving effect to the transactions contemplated herein, (i) the present value of the assets of such Guarantor, at a fair valuation, is in excess of the amount that will be required to pay its probable liability on its existing debts as said debts become absolute and matured, (ii) the property remaining in the hands of such Guarantor is not an unreasonably small capital and (iii) such Guarantor is able to pay its debts as they mature; and

(i)after giving effect to the issuance and sale of the Notes and the application of the proceeds thereof and due consideration to any rights of contribution and reimbursement, such Guarantor has received fair consideration and reasonably equivalent value for the incurrence of its obligations hereunder or as contemplated hereunder.

SECTION 10.    Notices.  All notices and communications provided for hereunder shall be in writing and sent (a) by facsimile if the sender on the same day sends a confirming copy of such notice by a recognized overnight delivery service (charges prepaid), (b) by registered or certified mail with return receipt requested (postage prepaid), or (c) by a recognized overnight delivery service (with charges prepaid), addressed (a) if to the Company or any Holder at the address or telecopy number set forth in the Note Purchase Agreement or (b) if to a Guarantor, in care of the Company at the Company’s address or telecopy number set forth in the Note Purchase Agreement, or in each case at such other address or telecopy number as the Company, any Holder or such Guarantor shall from time to time designate in writing to the other parties.  Any notice so addressed shall be deemed to be given when actually received.
SECTION 11.    Survival.  All warranties, representations and covenants made by each Guarantor herein or in any certificate or other instrument delivered by it or on its behalf hereunder shall be considered to have been relied upon by the Holders and shall survive the execution and delivery of this Guaranty, regardless of any investigation made by any of the Holders.  All statements in any such certificate or other instrument shall constitute warranties and representations by such Guarantor hereunder.
SECTION 12.    Jurisdiction and Process; Waiver of Jury Trial.
(a)Each Guarantor irrevocably submits to the exclusive jurisdiction of any New York or federal court sitting in New York City, over any suit, action or proceeding arising out of or relating solely to this Agreement or the Notes.  To the fullest extent permitted by applicable law, each Guarantor irrevocably waives and agrees not to assert, by way of motion, as a defense or otherwise, any claim that it is not subject to the jurisdiction of any such court, any objection that it may now or hereafter have to the laying of the venue of any such suit, action or proceeding brought in any such court and any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum.

(b)Each Guarantor agrees, to the fullest extent permitted by applicable law, that a final judgment in any suit, action or proceeding of the nature referred to in Section 22.2(a) brought in any such court shall be conclusive and binding upon it subject to rights of appeal, as the case may be, and may be enforced in the courts of the United States of America or the State of New York (or any other courts to the jurisdiction of which it or any of its assets is or may be subject) by a suit upon such judgment.

(c)The Company consents to process being served in any suit, action or proceeding solely of the nature referred to in Section 12(a) by mailing a copy thereof by registered or certified or priority mail, postage prepaid, return receipt requested, or delivering a copy thereof in the manner for delivery of notices specified in Section 10, to it.  Each Guarantor agrees that such service upon receipt (i) shall be deemed in every respect effective service of process upon it in any such suit, action or proceeding and (ii) shall, to the fullest extent permitted by applicable law, be taken and held to be valid personal service upon and personal delivery to it.  Notices hereunder shall be conclusively presumed received as evidenced by a delivery receipt furnished by the United States Postal Service or any reputable commercial delivery service.

(d)Nothing in this Section 12 shall affect the right of any holder of a Note to serve process in any manner permitted by law, or limit any right that the holders of any of the Notes may have to bring proceedings 

against the Company in the courts of any appropriate jurisdiction or to enforce in any lawful manner a judgment obtained in one jurisdiction in any other jurisdiction.

(e)EACH GUARANTOR WAIVES TRIAL BY JURY IN ANY ACTION BROUGHT ON OR WITH RESPECT TO THIS AGREEMENT, THE NOTES OR ANY OTHER DOCUMENT EXECUTED IN CONNECTION HEREWITH OR THEREWITH.

SECTION 13.    Miscellaneous.  Any provision of this Guaranty that is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction.  To the extent permitted by applicable law, each Guarantor hereby waives any provision of law that renders any provisions hereof prohibited or unenforceable in any respect.  The terms of this Guaranty shall be binding upon, and inure to the benefit of, each Guarantor and the Holders and their respective successors and assigns.  No term or provision of this Guaranty may be changed, waived, discharged or terminated orally, but only by an instrument in writing signed by each Guarantor and each Holder, except for a release and discharge of this Guaranty permitted by, and in compliance with, Section 1.2(b) of the Note Purchase Agreement.  The section and paragraph headings in this Guaranty are for convenience of reference only and shall not modify, define, expand or limit any of the terms or provisions hereof, and all references herein to numbered sections, unless otherwise indicated, are to sections in this Guaranty.  This Guaranty shall be construed and enforced in accordance with, and the rights of the parties shall be governed by, the law of the State of New York excluding choice-of-law principles of the law of such State that would require the application of the laws of a jurisdiction other than such State.
IN WITNESS WHEREOF, each Guarantor has caused this Guaranty to be duly executed as of the day and year first above written.
[___________]
By:                                  
Name: [________]
Title:    [________] of each of the above-named companies]U.S. DEPARTMENT OF JUSTICE

DRUG ENFORCEMENT ADMINISTRATION

MEMORANDUM OF AGREEMENT

This Memorandum of Agreement ("Agreement") is entered into by and between the United States Department of Justice, Drug Enforcement Administration (hereinafter "DEA") and PHARMERICA CORPORATION (hereinafter "PMC"), each a "Party" and collectively hereinafter the "Parties".

I. APPLICABILITY

This Agreement shall be applicable to PHARMERICA CORPORATION and any PHARMERICA retail pharmacies, current or future, within the United States, registered with DEA to dispense, distribute, or otherwise handle controlled substances or List I chemicals. Unless specifically stated herein, nothing contained in this Agreement will lessen, supplant or expand PMC's legal obligations under any statute, regulation, or law.

II. BACKGROUND

Based on investigations conducted by the DEA at eleven PHARMERICA retail pharmacies, under DEA Registration Numbers BV5369740, BP5312121, BP6553677, BP9444136, BP5703788, BP5723449, FK0624571, FP0954568, BG5758113, FP0640537 and BP5704324, the United States of America, acting through the United States Attorney's Offices for the Eastern District of Wisconsin, the Eastern and Western Districts of Virginia, and the District of Rhode Island, contends that it had certain civil penalty claims against PMC.

PharMerica acknowledges that its pharmacies, to include PharMerica Pharmacies specified in the above paragraph, on some occasions during the Covered Conduct period, dispensed controlled substances in a manner not consistent with its obligations under the CSA and the CSA's implementing regulations.

To avoid the delay, uncertainty, inconvenience, and expense of protracted litigation of the above referenced claims, PMC, DEA, and the U.S. Attorney's Office for the Eastern District of Virginia and the Western District of Virginia, entered into Settlement Agreements on January 8, 2014 and April 15, 2014, respectively.

Contemporaneous to this Agreement, PMC, DEA, and the U.S. Attorney's Offices for the Eastern District of Wisconsin and the District of Rhode Island are also entering into a Settlement Agreement.

III. TERMS AND CONDITIONS

A.            Intention of Parties to Effect Settlement

Based on PMC's acceptance of responsibility as stated in the Settlement Agreements, PMC agreed to enter into a compliance agreement, also referred to as "Memorandum of Agreement", as required by the DEA.

B.            Covered Conduct

For purposes of this Agreement, "Covered Conduct" shall mean the following conduct, whether it occurred at any of the PMC pharmacy locations listed above or at any other PMC Pharmacy locations throughout the United States.

(1)            PMC dispensed Schedule II controlled substances and failed to obtain valid prescriptions written by a practitioner, as required per 21 U.S.C. § 829(a), such violations included:

		(a)	PMC initiated partially or fully pre-populated templates/forms, transmitted via facsimile, for a practitioner to sign. Under these circumstances, the practitioner had yet made the determination, in the usual course of practice, that there was a legitimate medical purpose for the prescription. PMC's practice failed to meet the requirements of 21 U.S.C. § 829 (a) and 21 C.F.R. § 1306.04(a);

(b)            PMC dispensed Schedule II controlled substances and failed to obtain a written prescription prior to the dispensation took place in that a signed prescription was obtained after the fact, as required per 21 U.S.C. § 829(a) and 21 C.F.R. § 1306.11(a);

(c)            PMC dispensed Schedule II controlled substances pursuant to orders from long term care facilities that failed to include required elements, such as the patient's address, quantity prescribed, dosage form, practitioner's name, practitioner's address, practitioner's signature, and DEA registration number, in violation of 21 U.S.C. § 829 (a) and 21 C.F.R. § 1306.05(a);

(2)            PMC dispensed Schedule II controlled substances "refills" to patients without obtaining a new prescription.  The refilling of a Schedule II controlled substance is prohibited.  PMC failed to meet the requirements of 21 U.S.C. § 829 (a) and 21 C.F.R. § 1306.12(a).

(3)            PMC dispensed partially filled Schedule II controlled substances and failed to record on the prescription whether the patient was "terminally ill" or a "LTCF patient", as required per 21 U.S.C. § 829 (a) and   21 C.F.R. § 1306.13(b).  In addition, for each partial filling, PMC failed to record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist.

(4)            PMC dispensed partially filled Schedule II controlled substances in excess of the total quantity prescribed and for a period that exceeded 60 days from the issue date, both in violation of  21 U.S.C. § 829 (a) and 21 C.F.R. § 1306.13(b).

(5)            PMC dispensed emergency Schedule II controlled substances in violation of 21 U.S.C. § 829 (a) and 21 C.F.R. § 1306.11(d), and such violations included:

	
(a)

	
PMC failed to receive an oral authorization of a prescribing individual, as required by U.S.C. § 829 (a) and 21 C.F.R. § 1306.11(d);

	
(b)

	
PMC dispensed emergency Schedule II controlled substances and failed to dispense the quantities limited to the amount adequate to treat the patient during the emergency period, as required per 21 U.S.C. § 829 (a) and 21 C.F.R. § 1306.11(d)(1); and

	
(c)

	
PMC dispensed emergency Schedule II controlled substances and failed to notify the nearest office of the Administration when the practitioner failed to deliver the written prescription to the pharmacy within 7 days after authorizing an emergency oral prescription, as required per 21 U.S.C. § 829 (a) and 21 C.F.R. § 1306.11(d)(4).

	
(d)

	
PMC dispensed emergency Schedule II controlled substances based on the oral authorization by a practitioner and failed to immediately reduce the oral prescription to writing with all of the information required, as required per 21 U.S.C. § 829 (a) and 21 C.F.R. § 1306.11(d)(2).

(6)            PMC dispensed Schedule II controlled substances from emergency kits placed at long-term care facilities and failed to receive an oral authorization of a prescribing individual practitioner, as required per 21 U.S.C. § 829 (a) and 21 C.F.R. § 1306.11(d).

(7)            PMC pharmacists failed to exercise their corresponding responsibility to ensure that controlled substances were dispensed pursuant to prescriptions that were valid under 21 C.F.R. § 1306.05, and as required per 21 U.S.C. § 829 (a) and 21 C.F.R. § 1306.04(a).

(8)            PMC placed Schedule II controlled substances in emergency kits at long-term care facilities and later filed a DEA form 106 acknowledging that some controlled substances were missing.  PMC failed to provide effective controls and procedures to guard against diversion or theft of controlled substances from emergency kits located at long-term care facilities as required per 21 C.F.R. § 1301.71(a).

(9)            PMC dispensed Schedule III-V controlled substances in violation of 21 C.F.R. § 829(b)(c) and 21 C.F.R. § 1306.21(a), and such violations included:

	
(a)

	
PMC dispensed Schedule III–V controlled substances pursuant to Physician's Orders faxed by nurses and failed to obtain a paper prescription signed by a practitioner, or a facsimile of a signed paper prescription, or an oral prescription made by an individual practitioner and promptly reduced to writing;

(b)            PMC dispensed Schedule III-V controlled substances in emergency kits at long-term care facilities and failed to obtain a paper prescription signed by a practitioner, or a facsimile of a signed paper prescription, or an oral prescription made by an individual practitioner and promptly reduced to writing, as required per 21 C.F.R. § 829(b)(c) and 21 C.F.R. § 1306.21(a);

(c)            PMC dispensed Schedule III-V controlled substances pursuant to prescriptions with missing essential elements, such as the patient's address, quantity prescribed, dosage form, number of refills, practitioner's name, practitioner's address, practitioner's signature, and DEA registration number, as required per 21 U.S.C. § 829 (b)(c) and 21 C.F.R. § 1306.05(a)

(d)            PMC dispensed Schedule III-V controlled substances pursuant to orders from long term care facilities that did not include the required elements of a prescription, such as the patient's address, quantity prescribed, dosage form, number of refills, practitioner's name, practitioner's address, practitioner's signature, and DEA registration number, as required per 21 U.S.C. § 829 (b)(c) and 21 C.F.R. § 1306.05(a).

(10)            PMC failed to maintain, on a current basis, a complete and accurate record of each substance received, dispensed, or otherwise disposed of by him/her, as required per 21 U.S.C. § 827(a)(3) and 21 C.F.R. § 1304.21(a).

(11)            PMC failed to record on Copy 1 and 2 of DEA Forms 222 the number of commercial containers furnished and the dates on which the containers were shipped to the purchaser, as required per 21 U.S.C. § 828 and 21 U.S.21 C.F.R. § 1305.13(b).

(12)            PMC failed to record on Copy 3 of DEA Forms 222 the number of commercial containers furnished and the dates on which the containers were received by the purchaser, as required per 21 U.S.C. § 828 and 21 C.F.R. § 1305.13(e).

(13)            PMC failed to submit to the Virginia Prescription Monitoring Program all controlled substances dispensed as required per Title 54.1-2521 of the Code of Virginia.

C.            Term of Agreement

The obligations contained in this Agreement shall remain in full force and effect for a period of three (3) years from the effective date of this Agreement.

D.            Obligations of PHARMERICA

(1)            PMC shall dispense Schedule II controlled substances only pursuant to valid prescriptions written, signed, and dated on the day signed, by a practitioner, as required per 21 U.S.C. § 829(a) and 21 C.F.R. § 1306.11(a).

(2)            PMC shall not dispense "refills" of Schedule II controlled substance prescriptions.

(3)            PMC shall not dispense Schedule II controlled substances to a hospice patient pursuant to a faxed prescription that fails to indicate that it was written for a hospice patient.

(4)            In the case of an emergency situation, as defined by 21 C.F.R. § 290.10, PMC shall only dispense a Schedule II controlled substance upon receiving oral authorization of a prescribing individual practitioner, as per 21 U.S.C. § 829(a) and 21 C.F.R. § 1306.11, provided that:

(a)            The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a paper or electronic prescription signed by the prescribing individual practitioner);

(b)            The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in 21 C.F.R. § 1306.05, except for the signature of the prescribing individual practitioner;

(c)            If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and

(d)            Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of 21 C.F.R. §1306.05, the prescription shall have written on its face "Authorization for Emergency Dispensing," and the date of the oral order. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7-day period. Upon receipt, the dispensing pharmacist must attach this paper prescription to the oral emergency prescription that had earlier been reduced to writing. For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription with the original authorization and date of the oral order. The pharmacist must notify the nearest office of the Drug Enforcement Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.

(5)            PMC shall not partially fill Schedule II controlled substances without recording on the prescription whether the patient is "terminally ill" or an "LTCF patient."  In addition, for each partial filling dispensed, PMC shall record on the back of the paper prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist.  Information pertaining to current Schedule II prescriptions for patients in a LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if this system has the capability to permit:

(a)            Output (display or printout) of the original prescription number, date of issue, identification of prescribing individual practitioner, identification of patient, address of the LTCF or address of the hospital or residence of the patient, identification of medication authorized (to include dosage, form, strength and quantity), listing of the partial fillings that have been dispensed under each prescription and the information required in 21 C.F.R. § 1306.13(b).

(b)            Immediate (real time) updating of the prescription record each time a partial filling of the prescription is conducted.

(c)            Retrieval of partially filled Schedule II prescription information is the same as required by 21 C.F.R. § 1306.22(b)(4) and (5) for Schedule III and IV prescription refill information.

(6)            By no later than March 1, 2015, PMC shall implement systems to allow for the recording of partial fillings as a subset of the original prescription number such as .01, .02, .03, etc.  After this date, PMC shall not use a new serial number (prescription number) for each partial filling dispensed under the original prescription number.

(7)            PMC shall not partially fill Schedule II controlled substances in excess of the total quantity prescribed by the practitioner or for a period that exceeds 60 days from the issue date of the prescription.

(8)            PMC shall partially fill Schedule II controlled substances that were prescribed by a practitioner in the case of an emergency, as defined by 21 C.F.R. § 290.10, in compliance with 21 C.F.R. 1306.13.

(9)            PMC shall not fill a Schedule III-V controlled substance prescription that does not conform to the requirements of 21 C.F.R. § 1306.05, including but not limited to obtaining a paper prescription signed by a practitioner; a facsimile of a signed paper prescription; an oral prescription made by an individual practitioner and promptly reduced to writing; or an electronic prescription which meets the requirements of 21 C.F.R. §1306.08.

(10)            PMC shall not knowingly fill an invalid prescription or a prescription that it reasonably believes was issued for other than a legitimate medical purpose or by a practitioner acting outside the usual course of professional practice.

(11)            PMC shall not initiate partially or fully pre-populated templates/forms for a practitioner to sign, as PMC may not be characterized as the prescribing practitioner's agent for purposes of preparing the prescriptions.

(12)            PMC shall implement procedures to verify that the DEA registration number for the issuing prescriber of each controlled substance prescription is a valid, DEA registration number, independent of calling local DEA offices. Such verification shall be performed periodically using the NTIS or similar-reliable third party database where DEA registration changes are recorded. PMC is not precluded from contacting any DEA office to verify the legitimacy of a DEA registration, however, it is understood that the verification of a DEA registration number alone does not fulfill all the obligations of a pharmacist's corresponding responsibility.

(13)            PMC shall direct and train its pharmacists to fill prescriptions in accordance with the terms of this Agreement and that their responsibility under federal law requires them not to fill a prescription that such pharmacist knows or has reason to know was issued for other than a legitimate medical purpose or by a practitioner acting outside the usual course of professional practice.

(14)            PMC shall implement and maintain policies and procedures to ensure that Schedule II-V controlled substances are only dispensed pursuant to valid prescriptions and proper oral authorizations by a prescribing practitioner.

(15)            In connection with PMC's recordkeeping requirements pursuant to 21 C.F.R. § 1306.04, PMC agrees to implement no later than March 1, 2015 and thereafter to maintain records regarding the dispensing of controlled substances in electronic format, in addition to the regularly maintained paper files, including records relating to partial fillings of Schedule II controlled substance prescriptions and refills of Schedule III-V controlled substance prescriptions.  These records shall be made available to DEA Special Agents, Task Force Officers or Diversion Investigators, upon demand, without the need for a warrant or subpoena, provided that the DEA Special Agents, Task Force Officers or Diversion Investigators present appropriate identification.  PMC shall provide electronic reports of dispensing on an ad hoc basis in response to DEA requests within a reasonable time.

(16)            By no later than March 1, 2015 PMC shall implement, and thereafter shall maintain, systems to allow for the maintenance on a current basis of a complete and accurate record of each substance received, dispensed, or otherwise disposed of.

(17)            PMC shall maintain a compliance program in an effort to detect and prevent diversion of controlled substances as required under the CSA and applicable DEA regulations.  This program shall include procedures to identify the common signs associated with the diversion of controlled substances.  The program shall also include the routine and periodic training of all PMC pharmacy employees responsible for dispensing controlled substances on the elements of the compliance program and their responsibilities under the CSA and applicable DEA regulations.

(18)            PMC shall maintain a Department of Compliance which includes employees  with pharmacy-related training and managerial  experience, who shall be trained in relevant diversion-related issues to coordinate compliance efforts related to controlled substances.  The director of the compliance department shall report directly to the Board of Directors and not simultaneously be an employee of PharMerica's legal department, including but not limited to the general counsel.  Within one (1) month of the effective date of this Agreement, PMC will identify the director of the compliance department as a dedicated point of contact (including a name, title, address, telephone number and dedicated email address) for DEA.  The point of contact will be responsible for the implementation of PMC's obligations listed in this Memorandum of Agreement and on-going monitoring of its level of compliance.

(19)            PMC agrees that DEA personnel, during the term of this Memorandum of Agreement, may enter the PMC's registered locations at any time during regular operating hours upon presentation of a Notice of Inspection to verify compliance with this memorandum.

(20)            PMC shall abide by all state specific Prescription Drug Monitoring program regulations, to the extent required under applicable state law, contain the correct valid, and active practitioners DEA Registration number.

(21)            PMC shall abide by all regulations relating to the transfer of original prescription information for controlled substances listed in Schedule III, IV or V, as required by 21 C.F.R. § 1306.25.

(22)            PMC shall abide by all regulations relating to the registration and recordkeeping for Automated Dispensing Systems maintained at Long Term Care Facilities, as required by 21 C.F.R. § 1301.17(c), 1301.27, and 1304.04(a)(2). 

(23)            Upon the acquisition of a pharmacy, the newly acquired pharmacy shall adhere to the requirements of the CSA and its implementing regulations prior to dispensing any controlled substance medications and PharMerica shall take measures otherwise to bring the acquired pharmacy into compliance with the non-CSA provisions of this MOA within a reasonable time. 

	
E.

	
Release by DEA

In consideration of the fulfillment of the obligations of PMC under this Agreement, DEA hereby releases and agrees to refrain from filing any administrative actions against PMC based on the Covered Conduct or similar conduct at any other PMC pharmacy on or before the effective date of this agreement, within DEA's enforcement authority under 21 U.S.C. Sections 823 and 824.  Notwithstanding the release by DEA contained in the Paragraph, DEA reserves the right to seek to admit evidence of the Covered Conduct in any other administrative proceedings.  Further, nothing in this Paragraph shall prohibit any other agency within the Department of Justice, any State attorney general, or any other law enforcement, administrative, or regulatory agency of the United States or any State or political subdivision thereof ("law enforcement agency"), from initiating administrative, civil, or criminal proceedings with respect to the Covered Conduct. DEA shall, as obligated in fulfilling its statutory duties, assist and cooperate with any law enforcement agency that initiates an investigation, action, or proceeding, involving the Covered Conduct. At PMC's request DEA agrees to disclose the terms of this Agreement to any other law enforcement agency and will represent that PMC's compliance with this Agreement adequately addressed the allegations raised in the administrative proceedings by DEA as defined in the Covered Conduct.

	
F.

	
Release by PMC

PMC fully and finally releases the United States of America, its agencies, employees, servants, and agents from any claims (including attorney's fees, costs, and expenses of every kind and however denominated) which PMC has asserted, could have asserted, or may assert in the future against the United States of America, its agencies, employees, servants, and agents, related to the Covered Conduct and the United States investigation and prosecution thereof.

	G.	Reservation of Claims

Notwithstanding any term of the Agreement, specifically reserved and excluded from the scope and terms of the Agreement as to any entity or person (including PMC) are the following:

	
a)

	
Any civil, criminal, or administrative liability arising under Title 26, U.S. Code (Internal Revenue Code);

	
b)

	
Any liability to the United States (or its agencies) for any conduct other than the Covered Conduct subject to paragraph 5 of the Agreement;

	
c)

	
Any liability based upon such obligations as are created by this Agreement.

IV. MISCELLANEOUS

	A.	Binding on Successors

This Agreement is binding on PMC, and its respective successors, heirs, transferees, and assigns.

	B.	Costs

Each Party to this Agreement shall bear its own legal and other costs incurred in connection with this matter, including the preparation and performance of this Agreement.

	C.	No Additional Releases

This Agreement is intended to be for the benefit of the Parties and the Released Parties only and by this instrument the Parties do not release any claims against any other person or entity other than the Released Parties.

	D.	Effect of Agreement

This Agreement constitutes the complete agreement between the Parties.  All material representations, understandings, and promises of the Parties are contained in this Agreement, and each of the Parties expressly agrees and acknowledges that, other than those statements expressly set forth in this Agreement, it is not relying on any statement, whether oral or written, of any person or entity with respect to its entry into this Agreement or to the consummation of the transactions contemplated by this Agreement. Any modifications to this Agreement shall be set forth in writing and signed by all Parties. PMC represents that this Agreement is entered into with advice of counsel and knowledge of the events described herein. PMC further represents that this Agreement is voluntarily entered into in order to avoid litigation, without any degree of duress or compulsion.

By executing this Agreement, Pharmerica waives all rights to seek judicial review or to challenge or contest the validity of any terms or conditions of this Agreement.

	E.	Execution of Agreement

This Agreement shall become effective on the date of signing by the last signatory (the "Effective Date") and remain in effect for a period of three (3) years from the Effective Date. DEA agrees to notify PMC immediately when the final signatory has executed this Agreement.

	F.	Breach of Agreement

Only material and systemic violations of the provisions of this Agreement may constitute a breach of the Agreement. Parties shall have a reasonable time to cure any such violation.

G.            Effect of Breach

Violation of any material term of this Agreement may result in the immediate suspension of Pharmerica's DEA Certificate of Registration and in an administrative hearing, all pursuant to 21 U.S.C. § 824.  Further, nothing in this Agreement shall be construed as a waiver on the part of the Drug Enforcement Administration of its authority to utilize any other grounds for revocation or denial of a DEA registration.

  

H.            Disclosure

PMC and DEA may each disclose the existence of this Agreement and information about this Agreement to the public without restriction.

	I.	Execution in Counterparts

This Agreement may be executed in counterparts, each of which constitutes an original, and all of which shall constitute one and the same agreement.

	J.	Authorizations

The individuals signing this Agreement on behalf of PMC represent and warrant that they are authorized by PMC to execute this Agreement. The individuals signing this Agreement on behalf of DEA represent and warrant that they are signing this Agreement in their official capacity and that they are authorized by DEA to execute this Agreement.

UNITED STATES OF AMERICA

DATED:                        5-14-15                          /s/ Dennis A. Wichern

Dennis A. Wichern

Special Agent in Charge

Chicago Field Division

United States Drug Enforcement Administration

DATED:                    ___5-14-15                          /s/ Karl C. Colder

Karl C. Colder

Special Agent in Charge

Washington Field Division

United States Drug Enforcement Administration

PHARMERICA  CORPORATION

DATED:                        5/11/15                          /s/ Michael R. Manthei

Michael R. Manthei

Jeremy M. Sternberg

HOLLAND & KNIGHT LLP

DATED:                        5/11/15                          /s/ Thomas Caneris

Thomas Caneris

Vice President and General Counsel

PharMerica Corporation

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00251-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00251-of-00352.parquet"}]]