ARBOR PHARMACEUTICALS EZ-RX PROGRAM PHARMACY SERVICES AGREEMENT

Transcription

1 ARBOR PHARMACEUTICALS EZ-RX PROGRAM PHARMACY SERVICES AGREEMENT This Arbor Pharmaceuticals EZ-RX Program Pharmacy Services Agreement (this Services Agreement ) dated as of, 2017 (the Effective Date ) is made between Arbor Pharmaceuticals, LLC, a Delaware limited liability company, having its principal place of business at Six Concourse Parkway, Suite 1800, Atlanta, Georgia ( Arbor ) and, a corporation {or other business form}, having its principal place of business at ( Pharmacy ). Each of Arbor and Pharmacy may be referred to as a Party and, collectively, as Parties in this Services Agreement. WHEREAS, Arbor is in the business of marketing and selling prescription pharmaceutical products; WHEREAS, Arbor desires to engage Pharmacy to provide Services (as hereinafter defined below) to its customers under Arbor s EZ-RX program; WHEREAS, the Services Agreement seeks to ensure patient access to Arbor products at Pharmacy; WHEREAS, Pharmacy agrees to maintain sufficient Product inventory to meet anticipated demand and Arbor shall inform healthcare providers as such; and WHEREAS, Pharmacy desires to participate in Arbor s EZ-RX program and is willing and qualified to perform the Services in accordance with the terms of this Services Agreement. NOW, THEREFORE, in consideration of the foregoing premises and of the mutual covenants and subject to the terms and conditions set forth herein below, and intending to be legally bound, Pharmacy and Arbor agree as follows: 1 Definitions 1.1 Adverse Event shall mean any adverse event associated with the use of a drug in humans, whether or not considered drug-related, including the following: an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action. 1.2 Affiliate shall mean, in relation to a Party, any person, corporation, firm, partnership, or other entity which directly or indirectly through one or more intermediaries controls, is controlled by, or is under common control with such Party. An entity shall be deemed to control another entity if it: (i) owns, directly or indirectly, at least fifty percent (50%) of the outstanding voting securities or capital stock (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of such other entity, or has other comparable ownership interest with respect to any entity { }

2 other than a corporation; or (ii) has the power, whether pursuant to contract, ownership of securities, or otherwise, to direct the management and policies of the entity. 1.3 Applicable Laws shall mean all applicable provisions of any and all federal, national, state, provincial, and local statutes, laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, injunctions, awards, judgments, permits, and licenses of or from governmental authorities relating to or governing the use or regulation of the subject item, including, without limitation, the Federal health care program antikickback statute, 42 U.S.C. 1320a-7b(b), and the Federal Food, Drug, and Cosmetic Act, as amended ( FFDCA ), 21 U.S.C. 301 et seq., and its implementing regulations. 1.4 CMS means the U.S. Centers for Medicare & Medicaid Services. 1.5 Commercially Reasonable Efforts shall mean the care, resources, effort, knowledge and expertise as a reasonably prudent person experienced in, and knowledgeable of, such matters and duties of the kind and character contemplated herein would exercise under the circumstances. 1.6 FDA shall mean the United States Food and Drug Administration. 1.7 Patient shall mean a customer or patient who has been prescribed a Product. 1.8 Products shall mean the Arbor pharmaceutical products set forth in Exhibit B. 1.9 "Program shall mean Arbor s EZ-RX program, through which the Services set forth in Exhibit A shall be provided by Pharmacy Services shall mean the services to be provided hereunder by Pharmacy to Arbor as described in Exhibit A to this Services Agreement Regulatory Authority shall mean any United States (federal or state) court, governmental, regulatory or administrative body, including, but not limited to, FDA, CMS, State boards of pharmacy, and/or State departments of insurance that have responsibility for granting regulatory approval for the manufacture, distribution, dispensing, use, sale of, and reimbursement for the Product Term shall mean the duration of this Services Agreement, which includes the Initial Term and all subsequent Renewal Terms as set forth in Section Third Party shall mean any person or entity who or which is neither a Party nor an Affiliate of a Party Work Product shall mean all copyrights, patents, trade secrets, or other intellectual property rights associated with any ideas, techniques, inventions, or works of authorship developed or created by Pharmacy during the performance of Services hereunder. { } 2

3 2 Services 2.1 Pharmacy will provide Services to Arbor as set forth in Exhibit A. Pharmacy shall render the Services to Arbor in accordance with all the requirements set forth in Exhibit A and in a professional manner, in accordance with industry standards and Applicable Law. Pharmacy shall use Commercially Reasonable Efforts to fulfill its obligations in a timely manner. 2.2 As individual Pharmacy employees are assigned to perform the Services, Pharmacy will ensure such assigned individuals are available and qualified to perform such Services during the Term of this Services Agreement. 2.3 The Services set forth in Exhibit A are intended to help ensure that Patients receive products as recommended by their physicians and that such Patients are compliant with their medication requirements and treatment regimens, as well as to help ensure that the dispensing process is as effective and efficient as possible in furtherance of the Patients treatment goals. All Product communications regarding a Product s benefits or efficacy must also thoroughly explain the Product s health risks, side effects and important safety information (eg., black box warning). 2.4 Notwithstanding anything to the contrary set forth herein, including in the event Pharmacy becomes aware that the Services are inconsistent with or counter to any non-government third-party payor requirements, Pharmacy shall promptly advise Arbor so that appropriate adjustments, including, but not limited to, ensuring the Program is not offered to a beneficiary of said third-party payor, may be made. 2.5 Pharmacy shall sell and dispense the Products pursuant to a valid prescription written by a duly licensed health care practitioner with prescriptive authority and in accordance with Applicable Law. Pharmacy shall not distribute the Products to other entities for retail sale and shall not resell any Product to any other pharmaceutical distribution channel, including pharmaceutical wholesalers. Pharmacy shall (a) maintain sufficient Product inventory to meet anticipated demand and (b) upon successful completion of Pharmacy s credit check to Arbor s satisfaction, Pharmacy may purchase Product directly from Arbor as set forth on Exhibit D, purchase Product through its normal distribution channels including Third Party wholesalers. 2.6 Pharmacy shall not alter the Product packaging without Arbor s consent (except to remove the Product from the shipping containers and to separate the Products into smaller lots) and will not alter the Product labeling, except to add a prescription label to the Products, as permitted by Applicable Law. Pharmacy shall not alter, remove, or conceal any trademarks, service marks, copyrights, or drug registration numbers that appear on the Products or their packaging. Nothing in this Section 2.6 shall prohibit Pharmacy from removing Product from the containers as shipped and placing such Product into a smaller container or bottle. { } 3

4 2.7 With the exception of the use of a common carrier to dispense Products through a mailorder service, Pharmacy may not, at any time, use any Third Party to market, promote, sell or dispense the Product unless it has received prior approval from Arbor. 2.8 Except in the course of dispensing pursuant to a valid prescription, Pharmacy agrees not to repackage or cause any Third Party to repackage the Products except with Arbor s prior written consent. 2.9 The Recitals are incorporated herein. 3 Fees and Expenses 3.1 The parties agree that no Service Fees or any other amounts shall be paid to or from either party in connection with the Services and that each party will bear its own costs and expenses. 3.2 The parties agree that the Agreement is for the mutual benefit of the parties and has not and does not take into account the volume or value of any referrals, prescriptions, purchases, or purchases or dispensing of Arbor products or business otherwise generated (or potentially generated) between the parties. The parties acknowledge that Arbor may be required to publicly disclose certain terms of this Services Agreement including the identity of Pharmacy, the nature of the Services performed, and any payment or other transfer of value provided to Pharmacy under this Services Agreement. Pharmacy shall be responsible for providing all equipment, supplies, or facilities required to perform the Services 4 Amendments 4.1 Arbor reserves the right to modify the Services provided in Exhibit A and will inform Pharmacy of such requested changes in writing in a timely manner. Any change to Exhibit A to modify the Services must be set forth in a written amendment. 5 Reports 5.1 Subject to patient confidentiality and HIPAA, Pharmacy may use Program data in Pharmacy s ordinary course of business. 6 Records and Audits 6.1 Records. During the term of this Services Agreement and for a period of three (3) years thereafter (or such longer period as may be required by Applicable Law), Pharmacy shall maintain complete and accurate records related to its obligations hereunder, including with respect to any Services performed pursuant to this Services Agreement. 6.2 Audit. During the term of this Agreement and for a period of three (3) years thereafter, Arbor, or an independent auditing firm engaged by Arbor, shall have the right to audit Pharmacy upon reasonable notice to verify its performance and compliance with its { } 4

5 obligations under this Agreement. Arbor or such independent auditing firm will be provided access to any and all information reasonably necessary to perform such audit. Notwithstanding the foregoing, under no circumstances shall Pharmacy be required to disclose information contrary to Applicable Law or in violation of patient confidentiality. The cost of any such audit under this section shall be paid for solely by Arbor. 6.3 Arbor or its designee shall provide Pharmacy with at least 14 days notice of an audit, and the exact time and date of any such audit shall be mutually agreed upon by the Parties. 7 Regulatory Matters 7.1 Licenses. Pharmacy shall maintain all necessary and appropriate licenses to conduct its business. 7.2 Communications, Regulatory Inspections, and Notifications At all times, Arbor shall have responsibility for all communications with the applicable Regulatory Authorities regarding the manufacture, marketing, and sale of the Products Each Party shall notify the other within twenty-four (24) hours (or, if such twenty-four (24) hour period ends on a non-business day, then prior to noon on the next following business day) of receipt of any notice of any governmental agency inspection, investigation, or other inquiry, or other material governmental notice or communication (collectively investigation ), in each case which relates to the Program or the marketing, promotion, dispensing, and/or detailing of the Products during the Term. Pharmacy and Arbor shall discuss any response to observations or notifications received in connection with any such inspection, investigation, or other inquiry and if such investigation is directed at the Pharmacy, Pharmacy shall give Arbor an opportunity to comment upon any proposed response before it is made. In the event of disagreement concerning the form or content of such response, however, Pharmacy shall be responsible for deciding the appropriate form and content of any response with respect to any of its cited activities. Each Party will provide the other Party with copies of all correspondence received by it from, or filed by it with, any Regulatory Authority to the extent pertaining to the investigation. 7.3 Recall. In the event of any recall of a Product required by a Regulatory Authority for safety or efficacy reasons, Arbor shall credit or exercise Commercially Reasonable Efforts to replace at Arbor s own cost and expense all Products subject to the recall and previously delivered to Pharmacy. Arbor also shall consult with Pharmacy to establish a reasonable process for managing the recall. Arbor shall be responsible and promptly reimburse Pharmacy for all actual, reasonable expenditures incurred by Pharmacy (including, but not limited to, shipping costs) in connection with the recall of any Product, regardless of whether such recall was initiated by a Regulatory Authority, a voluntary act of Arbor, or otherwise, consistent with the recall process agreed to by the Parties and consistent with Healthcare Distribution Management Association (HDMA) industry guidelines. In the event the recall is not required by a Regulatory Authority for safety or efficacy reasons, but is instead requested by Arbor at its sole discretion, Arbor will be responsible for { } 5

6 determining the scope of the recall, including the number of units, timeframe for the recall, and criteria for completion, at no cost or expense to Pharmacy. 7.4 HIPAA Compliance. Notwithstanding anything to the contrary herein (including the Exhibits hereto), Pharmacy shall only provide information to Arbor in a manner consistent with Health Insurance Portability and Accountability Act, as amended, and implementing regulations ( HIPAA ). Accordingly, the Parties agree that Pharmacy shall only provide Arbor information that is de-identified in accordance with HIPAA s de-identification provision, 45 C.F.R (b)(2), unless Pharmacy: (i) has on file a valid, HIPAAcompliant authorization for each patient whose protected health information ( PHI ) is sought to be disclosed; or (ii) authorization is not required under Applicable Law in order to disclose the PHI. If Pharmacy does not have on file a valid, HIPAA-compliant authorization for each patient whose PHI is sought to be provided to Arbor, then Arbor represents and warrants that any request by Arbor for such PHI is for one of the public health activities exceptions codified at 45 C.F.R (b) and that the amount of PHI sought by Arbor shall be only that amount of PHI minimally necessary for Arbor to perform such public health activities. In such case, Arbor represents and warrants that it shall only use and/or disclose the PHI it receives from Pharmacy for such public health activities, and, upon request, Arbor shall provide Pharmacy reasonable written assurance at the time of Arbor s request for such PHI, that the unauthorized disclosure of the PHI by Pharmacy will satisfy the requirements of 45 C.F.R (b), or such other provision of HIPAA that would enable the contemplated disclosure. 7.5 Adverse Event Reporting Obligations. Pharmacy shall notify Arbor in the manner set forth on Exhibit C, attached hereto and incorporated herein, of any Adverse Event (whether unexpected, serious, or not serious), as soon as required under the applicable FDA regulations (21 C.F.R , , , & ). Individual Case Safety Reports (ICSRs) originating from any source such as health care professionals, patients, Regulatory Authorities, literature, and clinical trials shall be sent to Arbor within the time frames described under Section 5.7, even where further clarifications may be required. Any further information that Pharmacy may receive shall also be forwarded to Arbor within the same time frame described in Section 5.7. Arbor shall be responsible for all follow-up activities, including medical substantiation of reports from patients. In addition to ICSRs, the following types of cases shall be reported to Arbor within the time frames described under Section (even where no Adverse Event has occurred): medication error including administration of Products via an incorrect route; overdose (accidental or intentional), misuse, or abuse; drug exposure via the mother or father (or any other individual), including pregnancy and lactation; lack of effect of the product; drug interaction; and suspected transmission of an infectious agent by a medicinal product. { } 6

7 7.6 Individual Case Safety Reports Time Frame. Pharmacy agrees to provide Arbor with any ICSRs within one (1) calendar day after learning of an Adverse Event for serious cases and within five (5) calendar days of the awareness date for all other cases Reporting Format. All ICSRs shall be forwarded via or fax using the contact information set forth in Exhibit C (unless otherwise agreed by the parties). 7.7 Safety Related Regulatory Actions. Arbor and Pharmacy shall inform each other immediately of any safety related regulatory actions of which either Party becomes aware as it relates to any Product, including, but not limited to, a change to Product labeling or marketing restrictions imposed by a Regulatory Authority. 8 Covenants, Representations and Warranties 8.1 Covenants, Representations and Warranties of Both Parties. Each Party covenants, represents and warrants to the other Party, as of the Effective Date, that: it is duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it was organized; the person executing this Services Agreement on behalf of the Party is duly authorized to bind the Party to all terms and conditions of this Services Agreement; this Services Agreement, when executed and delivered by the Party, will be the legal, valid, and binding obligation of the Party, enforceable against the Party in accordance with its terms; and the execution, delivery and performance of this Services Agreement by the Party does not and will not conflict with or constitute a breach or default under its charter documents, delegations of authority, or any material agreement, contract, commitment, or instrument to which the Party is a party, or require the consent, approval or authorization of, or notice, declaration, filing or registration with, any Third Party or Regulatory Authority. 8.2 Covenants, Representations and Warranties of Arbor Arbor hereby further covenants, represents and warrants to Pharmacy that it shall comply with all Applicable Law with respect to its operations and its participation in this Agreement Product Warranty. Arbor hereby warrants that, at the time of delivery to Pharmacy hereunder, the Products (i) will not be adulterated or misbranded within the meaning of the FFDCA, and (ii) may be introduced into interstate commerce pursuant to the FFDCA. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, ARBOR MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS, INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF NON-INFRINGEMENT, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR { } 7

8 PURPOSE. ARBOR S SOLE LIABILITY TO PURCHASER WITH RESPECT TO DAMAGED OR DEFECTIVE PRODUCTS SHALL BE, IN ARBOR S DISCRETION, EITHER TO REPLACE SUCH PRODUCTS OR TO REFUND THE AMOUNT PAID TO ARBOR FOR SUCH PRODUCTS. 8.3 Covenants, Representations and Warranties of Pharmacy. Pharmacy hereby further covenants, represents and warrants to Arbor that: it has, and shall maintain during the term of this Agreement, all licenses, authorizations, registrations, and permits of all Regulatory Authorities required in order to perform Services within the Territory; and it shall comply with all Applicable Law with respect to its operations and its participation in this Agreement Pharmacy represents, warrants, and certifies that neither it nor any of its Affiliates, officers, directors, employees, contractors, or agents were or are excluded, debarred, suspended, proposed for exclusion or debarment, or otherwise determined to be ineligible to participate in Federal health care programs (as defined in 42 U.S.C. 1320a-7b(f)), convicted of a criminal offense related to the provision of health care items or services, or currently the subject of any investigation by the Office of Inspector General of the Department of Health and Human Services (collectively, an Adverse Enforcement Action ). Pharmacy shall notify Arbor within 24 hours if Pharmacy becomes the subject of an Adverse Enforcement Action. 9 Indemnification 9.1 Indemnification by Arbor. Arbor shall indemnify, defend and hold harmless Pharmacy and its Affiliates and their respective directors, officers, employees, and agents, from and against any and all liabilities, damages, losses, costs, and expenses (including the reasonable fees of attorneys) for Third-Party claims arising out of or resulting from: (a) negligence or wrongful intentional acts or omissions of Arbor or its Affiliates, in connection with the activities contemplated under this Services Agreement; (b) Product defects caused by Arbor; (c) patent and trademark infringement claims arising out of the manufacture, sale, or use of the Products; or (d) any material breach of any representation or warranty made by Arbor hereunder; except, in each case, to the extent due to the negligence or wrongful intentional acts or omissions of Pharmacy or its Affiliates. 9.2 Indemnification by Pharmacy. Pharmacy shall indemnify, defend, and hold harmless Arbor and its Affiliates and their respective directors, officers, employees, and agents, from and against any and all liabilities, damages, losses, costs, and expenses (including the reasonable fees of attorneys) for Third-Party claims arising out of or resulting from: (a) negligence or wrongful intentional acts or omissions of Pharmacy or its Affiliates, in connection with the activities contemplated under this Services Agreement, including, but not limited to Pharmacy Services; (b) Pharmacy s Services or (c) any breach of any representation or warranty made by Pharmacy hereunder; except, in each case, to the { } 8

9 extent due to the negligence or wrongful intentional acts or omissions of Arbor or its Affiliates. 9.3 Conditions to Indemnification. The obligations and liabilities of the Parties under this Section 9 with respect to Third-Party claims shall be subject to the following terms and conditions: The Party claiming indemnification ( Indemnified Party ) shall give written notice to the other Party (the Indemnifying Party ) of any assertion of a claim by a Third Party which might give rise to a claim by Indemnified Party against Indemnifying Party based on an indemnification obligation set forth in this Section 9, stating the nature and basis of said assertion and the amount thereof, to the extent known, within ten (10) business days after an officer of Indemnified Party learns of the claim or receives notice thereof In the event any action, suit or proceeding is brought against Indemnified Party, with respect to which Indemnifying Party may have liability under pursuant to this Section 9, the action, suit or proceeding shall, upon the written request of Indemnified Party, be defended (including all proceedings on appeal or for review which counsel for the defendant shall deem appropriate) by Indemnifying Party. Indemnified Party shall have the right to be represented by advisory counsel and accountants, at its own expense, and shall be kept informed of such action, suit, or proceeding at all stages thereof, whether or not it is so represented. Indemnifying Party shall make available to Indemnified Party and its attorneys and accountants all books and records of Indemnifying Party relating to such action, suit or proceeding. The Parties will render reasonable assistance to each other in order to ensure the proper and adequate defense of any such action, suit or proceeding Neither Party shall make any settlement of any claims that are the subject of a claim of indemnification under this Section 9 without the written consent of the other Party, which consent shall not be unreasonably withheld or delayed. 9.4 Insurance Arbor has procured and will maintain all necessary insurance and expects that the Pharmacy will procure and maintain during the Term of this Services Agreement, at its sole cost and expense, workers compensation and general liability insurance, as required by statute in each state in which Pharmacy s employees render Services hereunder At all times from the Effective Date through the date three (3) years after the termination or expiration of this Services Agreement, each Party shall maintain, at each respective Party s sole cost and expense, appropriate commercial general liability insurance and other professional liability insurance for itself in amounts, respectively, which are reasonable and customary, provided in no event shall the liability insurance amounts be less than $1,000,000 per occurrence and $3,000,000 in the aggregate limit of liability per year Each party shall provide the other party with written proof of such insurance upon request. { } 9

10 9.5 Limitations of Liability The amount of any losses to which the Indemnifying Party is liable, shall be reduced by the amount of any insurance proceeds actually paid to the Indemnified Party NOT WITHSTANDING THE FOREGOING, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR SPECIAL, PUNITIVE, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, OR DAMAGES FOR LOSS OF PROFIT, WITH RESPECT TO ANY CLAIM ASSERTED BY THE OTHER PARTY HEREUNDER The provisions of Section shall not limit: (i) liability for either Party s breach of any Confidentiality obligation hereunder, including but not limited to those described in Section 11 of this Services Agreement; (ii) liability for infringement of the other Party s intellectual property rights; (iii) a Party s indemnification obligations; or (iv) damages caused by a Party s willful misconduct. 10 Term and Termination 10.1 Term. The Initial Term of this Services Agreement shall begin on the Effective Date and, unless terminated earlier as provided herein, shall continue for twelve (12) months, upon which date this Services Agreement shall automatically renew for successive, one-year Renewal Terms unless either Party shall notify the other Party of its desire to terminate this Services Agreement prior to ninety (90) days before the expiration of the Initial Term or Renewal Term Termination Either party may terminate this Services Agreement without cause, in whole or in part, with respect to any Product, by giving the other party thirty (30) days prior written notice Either Party may terminate this Services Agreement in the event of a material breach of this Services Agreement by the other Party, which breach is not cured within thirty (30) days after the non-breaching Party gives written notice to the breaching Party requesting that the breach be remedied Either Party may immediately terminate this Services Agreement upon written notice to the other Party upon: (i) the other Party becoming insolvent; (ii) upon a Party s making an assignment for the benefit of its creditors; (iii) upon the initiation by or against either Party of insolvency, receivership, or bankruptcy proceedings, or any other proceedings for the settlement of that Party s debts; or (iv) upon a Party s dissolution or ceasing to do business Effect of Termination. All rights conferred hereunder, other than those intended to survive beyond termination or expiration, shall cease upon the termination or expiration of this Agreement. Pharmacy shall cease its data generation, reporting and related components of this Agreement. Notwithstanding the foregoing, Sections 3, 6, 7.3, 8, 9, 10, 11, and 13 shall survive any termination or expiration of this Services Agreement. { } 10

11 11 Confidentiality 11.1 Confidential Information. Arbor and Pharmacy acknowledge and agree that in the performance of this Services Agreement, each Party may have access to confidential or proprietary information of the other, including trade secrets, marketing and business plans, customer lists, financial information, personnel information, technical information, processes, formulas, procedures, and operations (collectively, Confidential Information ). Notwithstanding the foregoing, Confidential Information does not include information that (i) is or becomes generally available to the public or within the industry to which such information relates, other than as a result of a breach of this Services Agreement; (ii) is already known by the receiving Party at the time of disclosure, as evidenced by the receiving Party s written records; (iii) becomes available to the receiving Party on a nonconfidential basis from a source that is entitled to disclose it on a non-confidential basis; or (iv) was or is independently developed by or for the receiving Party without use of or reference to the Confidential Information of the disclosing Party, as evidenced by the receiving Party s written records. Confidential Information shall remain the exclusive property of the disclosing Party Nondisclosure Obligations. Each Party agrees that (i) it shall maintain, and cause its Affiliates, officers, directors, employees, contractors, and agents to maintain, the confidentiality of the other Party s Confidential Information, (ii) it shall not disclose the other Party s Confidential Information to any Third Party, other than those of its employees and agents who need to know the information in connection with this Services Agreement and who are bound by similar obligations of confidentiality, and (iii) it shall use the other Party s Confidential Information solely in connection with its performance under this Services Agreement. Nothing herein shall prevent the receiving Party from complying with a legal obligation to disclose Confidential Information, provided that the receiving Party promptly notifies the other Party of such required disclosure and cooperates with the other Party s efforts to obtain confidential treatment for the information required to be disclosed Publicity. Neither Party shall originate any publicity or make any press release or other public disclosure regarding this Services Agreement or the transactions contemplated hereby without the other Party s express prior written consent, except as required under Applicable Law, by any Regulatory Authority or other governmental authority, or by the rules of any stock exchange on which the shares of the disclosing party are listed, in which case the Party required to make the press release or public disclosure shall obtain the prior approval of the other Party as to the form, nature, and extent of such press release or public disclosure Return of Confidential Information. Following the termination or expiration of this Agreement, each Party, upon the request of the other Party and at the other Party s expense, shall promptly certify the return or destruction of the other Party s Confidential Information. 12 Intellectual Property { } 11

12 12.1 Ownership of Confidential Information and Work Product. Each party shall own their own Confidential Information. Arbor shall own Work Product which shall be considered work made for hire for Arbor and Pharmacy irrevocably assigns and transfers to Arbor all right, title, and interest it may have in such Work Product. Upon the request of Arbor and at Arbor s reasonable expense, Pharmacy shall take such further actions, including the execution and delivery of instruments of conveyance necessary to obtain legal protection in any country for such Work Product and for the purpose of vesting title thereto in Arbor. Neither Arbor nor any of its successors or assigns, may provide any Confidential Information obtained from Pharmacy, including but not limited to, patient identification information, patient addresses, phone numbers, patient medical information, patient drug therapy history, or any other information which identifies the patient in any manner, to any other pharmacy, domestic or foreign Trademarks. Neither Party shall advertise or use any trademarks, service marks and/or symbols of the other Party without first receiving the written consent of the Party owning the mark and/or symbol, except that Pharmacy may reference Arbor and the Product names, trademarks, service marks, and/or symbols in connection with its performance of the Services. 13 Miscellaneous 13.1 Relationship of the Parties. The relationship of the Parties is that of independent contractors, and neither Party shall incur any debts or make any commitments for the other Party except to the extent expressly provided in this Services Agreement. Nothing in this Services Agreement is intended to create or shall be construed as creating between the Parties the relationship of joint venturers, co-partners, employer/employee, or principal/agent Notices. All notices and other communications hereunder shall be in writing and shall be deemed given: (i) when delivered personally; (ii) when delivered by facsimile transmission (receipt verified); (iii) when received or refused, if mailed by registered or certified mail (return receipt requested), postage prepaid; or (iv) when delivered, if sent by express courier service, to the Parties at the following addresses (or at such other address for a Party as shall be specified by like notice; provided, however, that notices of a change of address shall be effective only upon receipt thereof): If to Pharmacy: Fax: { } 12

13 If to Arbor: Arbor Pharmaceuticals, LLC Attn: Vice President, Commercial Operations Six Concourse Parkway, Suite 1800 Atlanta, GA Fax: or to such address or addresses the Parties hereto may designate for such purposes during the term hereof Binding Effect and Assignment. During the Term, the rights of either Party under this Services Agreement shall not be assigned nor shall the performance of either Party s duties hereunder be delegated, without the other Party s written consent, which shall not be unreasonably withheld. Notwithstanding the foregoing, Either Party may assign this Services Agreement, without any consent of Pharmacy, to an Affiliate or to an entity that acquires all or substantially all of the business or assets of Arbor to which this Services Agreement pertains (whether by merger, reorganization, acquisition, sale or otherwise). All of the terms and provisions of this Services Agreement shall be binding upon, inure to the benefit of, and be enforceable by the Parties hereto and their respective permitted successors and assigns Dispute Resolution. For any dispute or claim arising out of or relating to this Services Agreement, of breach hereof, the Parties, prior to filing any action as provided herein, shall in good faith first negotiate towards a written resolution of such dispute or claim for a thirty (30) day period from the date of receipt of a Party s request for such negotiation. Such negotiations shall be conducted by managers of each Party who have full authorization to finally resolve any such dispute or claim. Notwithstanding the foregoing, each Party expressly reserves the right to seek interim or temporary judicial relief, without limitation, any injunction or other preliminary relief from a court of competent jurisdiction, Georgia law shall be the governing law, and alternative dispute resolution will be conducted in Atlanta, Georgia. State or federal courts in Atlanta, Georgia shall also be the venue for resolution of any disputes under this Agreement Governing Law. This Agreement shall be governed by and construed according to the laws of the State of Georgia, without regard to its conflict of laws principles, unless Pharmacy s state s law supersedes Georgia law Severability. If any provision of this Agreement is declared invalid or unenforceable by a court or other body of competent jurisdiction, the remaining provisions of this Agreement shall continue in full force and effect Force Majeure. Neither Party shall be liable for any delay or default in such Party s performance hereunder if such default or delay is caused by events beyond such Party s reasonable control, including but not limited to, acts of God; regulation or law or other action or failure to act by a government or an agency thereof; war or insurrection; civil { } 13

14 commotion; destruction of production facilities or materials by earthquake, fire, flood, or weather; labor disturbances; epidemic; or failure of public utilities or common carriers Headings. The section headings or subheadings set forth in this Services Agreement are intended only as a convenience and shall not be given any effect to interpret the provisions of this Services Agreement Entire Agreement; Amendments; Waivers. This Services Agreement, the Exhibits, and any amendments thereto constitute the entire understanding between the parties and supersede any contracts, agreements, or understandings (oral or written) of the parties with respect to the subject matter hereof. No term of this Services Agreement may be amended except upon written agreement of both Parties, unless otherwise provided in this Services Agreement. Failure by either Party to insist upon strict compliance with any term of this Services Agreement in any one or more instances shall not be deemed to be a waiver of its rights to insist upon such strict compliance with respect to any subsequent failure Counterparts. This Services Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. IN WITNESS WHEREOF, the Parties have executed this Arbor Pharmaceuticals Regional specialty Pharmacy Services Agreement by their respective duly authorized officers or representatives as of the date indicated below. ARBOR PHARMACEUTICALS, LLC PHARMACY By: Name: Thom Rowland Title: VP, Commercial Operations Date: By: Name: Title: Date: { } 14

15 EXHIBIT A Arbor Pharmaceuticals EZ-RX Program Services to be Performed by Pharmacy This Exhibit A describes the Services to be provided to Arbor by Pharmacy in connection with the Arbor Pharmaceuticals Regional specialty Pharmacy Program. Capitalized terms (if any) used herein and not otherwise defined will have the meanings given to them in the Section 1 of the Services Agreement. No modification of this Exhibit A will be valid unless contained in a written agreement signed by both Parties. Arbor and Pharmacy acknowledge and agree that: (i) pursuant to the terms and conditions provided in the Services Agreement, any fees, expenses or other costs in excess of the Services Fees must be authorized by Arbor in writing, in advance of any additional Services being performed; and (ii) Arbor will be under no obligation to pay Pharmacy any fees, expenses, or costs in excess of the Service Fees that are not properly authorized as required herein and under the terms of the Agreement. 1 Dispensing of Products to Patients 1.1 Pharmacy Operations. Pharmacy operations shall be maintained during Pharmacy s normal business hours to receive Patient prescription orders and as otherwise necessary to provide appropriate pharmaceutical services in accordance with Applicable Law. Pharmacy shall advise Patients seeking to place orders through the Program of any limits on their eligibility to participate and receive Services. Verbal orders from prescribers will be taken at Pharmacy s discretion where permitted by Applicable Laws. 1.2 Patient Eligibility. Upon receipt of a valid prescription and other documentation specified by Arbor pursuant to the Program, Pharmacy will: (i) confirm the Patient s eligibility to receive Services, and (ii) dispense such prescription in accordance with this Services Agreement, Applicable Law, and professional standards. 1.3 Professional Standards. Pharmacy shall perform all required Services in accordance with Applicable Law, including, but not limited to, prescription evaluation and record-keeping, fulfillment, drug utilization review, and patient counseling, in connection with the dispensing of the Product to a Patient. 1.4 Pharmacy may fulfill all Product prescriptions through a mail order service in such a manner that customers shall receive their products within three (3) business days following receipt of all patient information. Customer orders completed prior to 2:00 p.m. shall be shipped the same day. Customer orders completed after 2:00 p.m. shall be shipped the following business day. Prescriptions may be filled by Pharmacy for no more than a ninety (90) day supply in any one order. 1.5 Except for copay assistance or patient discounts offered by Arbor to Patients pursuant to Exhibit A section 3, or in connection with Pharmacy s determination to waive copayments for patients in financial need, Pharmacy will not offer any discounts or impose any premiums on the price charged by Pharmacy to Patients ordering a Product under any { } 15

16 circumstances without the express prior written consent of Arbor. Collection of amounts owed to Pharmacy from Patients is the sole responsibility of Pharmacy and in no event shall Arbor be responsible for any such amounts. 1.6 Pharmacy shall process prescription refills in accordance with its normal business practices and in accordance with Applicable Law unless otherwise set forth herein. 1.7 Pharmacy shall not provide any data pertaining to the Program to any Third Party outside Pharmacy s ordinary course of business, without the written consent of Arbor including, but not limited to, patient and physician information. 2 Coordination of Benefits 2.1 Pharmacy will provide standard pharmacy coordination of benefits services for Patients including benefits investigations/verifications for Patients. 2.2 If completion of a specific prior authorization ( PA ) form is required by a payor, Pharmacy will coordinate with the prescriber and insurance provider as appropriate to facilitate the PA process. Pharmacy will not complete PA forms, appeals forms or write letters on behalf of the prescriber for any Arbor E-ZRX covered products. Pharmacy s prior authorization services for any Arbor E-ZRX covered products shall be administrative, not promotional, in nature. 3 Co-pay Assistance and Patient Discount Services 3.1 Pharmacy shall not offer co-pay assistance to any patient who is insured by any federal or state healthcare programs (including TriCare, Medicaid, Medicare, or any other federal or state healthcare programs) and Pharmacy represents and warrants that it has policies and procedures in place to effectively exclude such patients from all Arbor co-pay assistance programs. 3.2 Pharmacy will offer a cash discount to Patients who are either (1) uninsured, or (2) enrolled in a Medicare Part D Plan or Medicare Advantage Part D Plan ( Part D Patients ), subject to the following conditions and requirements: The cash price to be offered on a Product to any such Patient will be determined by Arbor, and Pharmacy may not charge the patient any additional dispensing fee or other amount Arbor will reimburse the Pharmacy for the ingredient cost of the dispensed Product plus a dispensing fee, which will be consistent with ingredient cost reimbursement and fair market value dispensing fees paid by third party payors for similar products in the industry For Part D Patients, the following additional provisions will apply to a cash discount offer: { } 16

17 The Pharmacy will inform the Patient that the Patient is free to submit a claim for the Product to the Patient s Part D Plan consistent with the Plan s terms, but that, if the Patient elects to receive the cash price, the Patient may not submit a claim to the Patient s Part D Plan and may not submit the amount of the cash price to the Patient s Part D plan to count toward deductibles, True Out of Pocket Expenses (TrOOP), or any other requirement or co-insurance amount under the Part D Plan The Pharmacy may not submit any claim for the Product to the Patient s Part D Plan or any other third party payor, and may not submit the amount of the cash price to the Patient s Part D plan to count toward a deductible, TrOOP, or any other requirement or co-insurance amount under a Part D Plan A cash discount offered hereunder on a Product is not contingent on the Patient s use or purchase of any other Arbor product, or any other product or service offered by Pharmacy. Pharmacy may not condition the offer of a cash discount hereunder on the Patient s purchase of any other product or service from Pharmacy Arbor and Pharmacy each represents and warrants that it will not use a cash discount offer for a Product, or the materials relating thereto, to promote or influence a Patient to purchase or use any other Arbor Product, or any other products or services offered by Pharmacy. 4 Refill Reminders 4.1 Pharmacy shall offer Patients its standard pharmacy refill reminders. 4.2 Pharmacy hereby represents and warrants that when providing Services under this Exhibit A that involve contacting Patients, Pharmacy shall comply with all Applicable Law, including, without limitation, those laws, regulations, and rules governing communications made by telephone call, recording of calls, telephone messages, text messages, and/or e- mails, including, without limitation, the Telephone Consumer Protection Act and its implementing regulations, the Telemarketing and Consumer Fraud and Abuse Prevention Act, the Controlling the Assault of Non-Solicited Pornography and Marketing Act of 2003, the Federal Trade Commission s Telemarketing Sales Rule, and state and local equivalents. 5 Additional Requirements 5.1 Pharmacy shall comply with following additional requirements when performing Services hereunder: Pharmacy will not discuss any indication or manner of use of the Product that is not described in the FDA-approved Product labeling. Any patient requests for information regarding off-label uses will be referred to Arbor s Medical Affairs Department at medinfo@arborpharma.com or All written materials provided to Patients by Pharmacy must be approved by Arbor in advance. { } 17

18 5.1.3 Pharmacy and Arbor will jointly develop scripts and talking points for Pharmacy personnel to use during calls. Such scripts and talking points will be subject to approval by Arbor If Pharmacy is informed of any Adverse Event relating to the Product in the course of providing Services hereunder, Pharmacy will report such Adverse Event to Arbor in accordance with Section 7.5 of this Services Agreement. 6 Propriety of Services 6.1 Both parties acknowledge and agree that Services and activities set forth in the Agreement are reasonably necessary to accomplish a commercially reasonable and appropriate business purpose and that the Services do not and shall not involve the counseling or promotion of a business arrangement or other activity that violates any state or federal law, and are not intended to serve, either directly or indirectly, as a means of marketing a Product. 6.2 Both parties acknowledge and agree that the entry into and performance of the Agreement has not and shall not impact or influence the determinations of Pharmacy regarding the dispensing and/or use of Arbor products and Pharmacy shall not take any action (i.e., switching or recommending that patients switch to any Arbor Product) except as determined to be clinically appropriate by a licensed health care professional and in accordance with a valid prescription and applicable coverage criteria as established by the government or other third party payer. { } 18

19 EXHIBIT B Arbor Specialty Products Included in the Arbor Pharmaceuticals EZ-RX Program Edarbi Edarbyclor BiDil Evekeo Zenzedi Sklice Otovel TM Horizant Any and all other products commercialized or to be commercialized by Arbor following written notice in the form of a letter that such launch products are to be included in the EZ-RX Program { } 19

20 EXHIBIT C Adverse Event Reporting Contact Information Arbor Pharmaceuticals, LLC Primary: Evan Scullin, MD Medical Director Tel: Fax: escullin@arborpharma.com Secondary: Lawrence Anochie Sr. Manager Drug Safety Tel: Fax: lanochie@arborpharma.com For all Adverse Event, Product Complaints: Tel: Fax: aereports@arborpharma.com For all Medical Information Requests: Phone: Fax: medinfo@arborpharma.com { } 20

21 EXHIBIT D DIRECT PURCHASES FROM ARBOR 1. Direct Purchase. Upon receipt of Arbor s prior written consent, Pharmacy may exclusively purchase directly from Arbor the following Products at the prices set forth below: Product NDC# Discount off WAC Edarbi 5% 2% Edarbyclor 5% 2% BiDil 5% 2% Sklice 5% 2% Otovel 5% 2% Horizant 5% 2% Prompt Pay Discount (30 days) 2. Case Quantity Minimums. Pharmacy may only purchase such Products in case quantities and Pharmacy shall not resell any Product purchased hereunder to any other distribution channel, including pharmaceutical wholesalers. 3. Orders. Pharmacy shall submit purchase orders to Arbor in accordance with Arbor s instructions. All purchase orders are subject to Arbor s review and approval. Pharmacy shall be obligated to purchase, and Arbor shall be obligated to deliver, such quantities of Products as are set forth in each purchase order that is accepted in writing by Arbor. 4. Shipment. All Products purchased hereunder shall be shipped by Arbor or its agent, at Arbor s sole expense, to Purchaser or to Pharmacy s designee as specified in the applicable purchase order. Title to and risk of loss of the Products will pass to Pharmacy when the Products are delivered to Pharmacy. Pharmacy shall promptly report any damage, defect, loss in transit or other shipping error following Pharmacy s discovery of same. 5. Purchase Price. Prices are expressed as a percentage discount off of WAC. WAC means the wholesale acquisition cost of the Product, as determined by Arbor. Arbor shall notify Pharmacy in writing of changes in WAC. Invoices and subsequent discounts for the Products purchased hereunder will be based on the WAC in effect on the date the Products are shipped. All discounts offered hereunder are discouns or other reductions in price for purposes of the Federal health care program antikickback statute discount exemption, 42 U.S.C. 1320a-7b(b)(3)(A). The parties shall comply with the conditions set forth in 42 C.F.R (the Discount Safe Harbor ). Pharmacy shall retain documentation provided by Arbor relating to all discounts provided hereunder and shall fully and accurately disclose any such discounts as required by law, including providing such documentation to authorized government officials on request to the extent required under the Discount Safe Harbor. The purchase of Product by Pharmacy is not dependent { } 21