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  1. Applicable Provisions. Unless a separate, stand-alone written agreement exists between the Parties, these terms and conditions of sale (the “Agreement”) between QuVa Pharma, Inc. (“QuVa”) and customer (“Customer” and, together with QuVa, the “Parties”) represent the sole and complete agreement with respect to the product(s) purchased by Customer (“Product” or “Products”) and supersede any and all other understandings. QuVa rejects those provisions of any order, offer, or other communication from Customer, which are in additional to, different from, or conflict with the terms contained herein. 

  2.  Orders. All orders will be shipped FOB Destination, freight prepaid, and title and risk of loss for the Products shall pass from QuVa to Customer at the time of delivery. Additional charges shall apply for expedited shipping. Any shipment upgrade to currently placed orders must be received by 5 p.m. (CST) on the day prior to Products’ estimated shipment date.  

  3. Payment and Terms. All accounts or monies due to QuVa shall be payable at its offices located at 3 Sugar Creek Center Blvd, Suite 250, Sugar Land, Texas 77478 (Attn: Accounts Receivable) on or before thirty (30) days following date of shipment. Service charges on any account over thirty (30) days past due shall accrue at the rate of 1.5% per month (18% per annum) or the maximum non-usurious rate at the time the account is thirty (30) days past due, whichever is lower. In the event the account is past due, Customer agrees to pay all of QuVa’s expenses relating to the collection of such overdue amounts, including reasonable attorney’s fees and court costs. Time is of the essence with respect to payment.

  4. Representations and Warranties
    1. QuVa represents and warrants as follows:
      1. QuVa has and will maintain, in full force and effect, all licenses and permits required under applicable federal, state and local law for it to provide the Products under this Agreement;

      2. QuVa shall comply with all applicable federal, state and local laws governing the handling, sale, and distribution of the Products under this Agreement;

      3. The label affixed to the Products sold under this Agreement will identify QuVa as the compounding facility and conform to all laws and regulations governing the labeling of 503B products; and  iv.

      4. At the time of delivery, the Products shall (i) be in conformity with the Federal Food, Drug and Cosmetic Act, as amended (the “FDCA”), and the regulations promulgated thereunder; (ii) not be adulterated or misbranded, within the meaning of the FDCA as a result of any act or omission of QuVa; and (iii) be manufactured in compliance with cGMPs and all applicable laws and regulations and shall be free from defects in materials and workmanship. QUVA MAKES NO OTHER REPRESENTATIONS OR WARRANTIES OF ANY KIND REGARDING THE PRODUCTS, IMPLIED OR STATUTORY, AND DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON- INFRINGEMENT, OR IMPLIED WARRANTIES ARISING FROM THE COURSE OF PERFORMANCE.   

    2. Customer represents and warrants to QuVa as follows:
       
      1. Customer has the legal authority to outsource its request for the Products to QuVa; 

      2. Customer has all federal, state and local licenses, permits and authorizations required to purchase the Products under this Agreement; 

      3. The Products provided by QuVa under this Agreement will be for administration to patients  and shall not be offered for resale; 

      4. Customer shall retain all responsibility for patient billing and for complying with all applicable federal, state and local laws concerning reimbursement for the Products purchased under this Agreement; 

      5. Customer shall comply with all applicable federal, state and local laws governing the purchase, handling, storage, and administration of the Products purchased under this Agreement; and 

      6. Customer is a sophisticated purchaser of the Products purchased under this Agreement and is aware of the uses, benefits, limitations, hazards, potential injurious properties, storage and administration requirements of such Products purchased from QuVa and has independently evaluated the safety and clinical use of the Products purchased and has deemed these formulations to be clinically appropriate.  Further, Customer acknowledges that QuVa is strictly relying upon Customer’s determination that the Products received from QuVa are appropriate and thereby assumes all liability and risk in connection with their use or administration, including, without limitation, any direct or indirect injury arising therefrom.  Except as set forth herein, QuVa makes no representation or warranty as to the formulation or labeling of the Products except that such formulation and labeling shall be in accordance with the request transmitted and shall meet all legal and regulatory requirements for labeling of 503B products. 

  5. Indemnity. NOTWITHSTANDING ANYTHING EXPRESSED IN THIS AGREEMENT TO THE CONTRARY: 

    1. QUVA AGREES TO INDEMNIFY, HOLD HARMLESS, AND, IF REQUESTED, DEFEND CUSTOMER AND ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS AND AFFILIATES FROM AND AGAINST ANY AND ALL DAMAGES, INJURIES, LIABILITIES AND COSTS (INCLUDING REASONABLE ATTORNEYS’ FEES) RESULTING FROM ANY THIRD PARTY CLAIM ARISING FROM ANY BREACH OF THIS AGREEMENT BY QUVA, OR THE NEGLIGENCE OR WILLFUL MISCONDUCT OF QUVA OR ANY OF ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, OR AFFILIATES.  

    2. CUSTOMER AGREES TO INDEMNIFY, HOLD HARMLESS, AND, IF REQUESTED, DEFEND QUVA AND ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS AND AFFILIATES FROM AND AGAINST ANY AND ALL DAMAGES, INJURIES, LIABILITIES AND COSTS (INCLUDING REASONABLE ATTORNEYS’ FEES) RESULTING FROM ANY THIRD PARTY CLAIM ARISING FROM ANY BREACH OF THIS AGREEMENT BY CUSTOMER, THE USE OR ADMINISTRATION BY CUSTOMER OF ANY PRODUCT SOLD UNDER THIS AGREEMENT, OR THE NEGLIGENCE OR WILLFUL MISCONDUCT OF CUSTOMER OR ANY OF ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, OR AFFILIATES. 

    3. THE INDEMNIFY PROVISIONS SET FORTH IN THIS SECTION 5 WILL NOT IN ANY WAY LIMIT ANY OTHER STATUTORY, REGULATORY OR COMMON LAW DEFENSE AND HOLD HARMLESS RIGHTS TO WHICH EITHER PARTY MAY BE ENTITLED. SAID INDEMNITY IS IN ADDITION TO ANY OTHER RIGHTS THAT THE INDEMNIFIED PARTY MAY HAVE AGAINST THE INDEMNIFYING PARTY AND WILL SURVIVE THE TERMINATION OF THIS AGREEMENT. 

  6. Limitation of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY LOST PROFITS, LOSS OF DATA, LOSS OF USE, BUSINESS INTERRUPTION, OR OTHER SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, OR CONSEQUENTIAL DAMAGES, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY, ARISING FROM PERFORMANCE UNDER, OR RELATING TO, THIS AGREEMENT OR THE PRODUCTS PROVIDED HEREUNDER. THIS SECTION SHALL  SURVIVE THE TERMINATION OR EXPIRATION OF THIS AGREEMENT. 

  7. Confidentiality. For purposes of this Agreement, “Confidential Information” includes any and all oral, written, graphic, electronic or machine readable information of a Party, whether provided to the other Party before or after the date hereof, including, but not limited to, a Party’s business methods, business policies, products, pricing procedures, techniques, trade secrets, fees or financial information or other knowledge or processes developed by a Party or any other information relating to or dealing with the business operations or activities of a Party.  Confidential Information also includes any analyses, compilations, studies or other documents or data prepared by a Party or any of its affiliates, members, partners, shareholders, directors, officers, employees, consultants, agents or advisors that contain, reflect or are based on, in whole or in part, any such Confidential Information. 

    For a period of three years from the date of Customer’s most recent purchase under this Agreement, a Party receiving Confidential Information (the “Receiving Party”) from the other Party (the “Disclosing Party”) agrees to receive and hold all such Confidential Information of the Disclosing Party in strict confidence and to disclose it only to those affiliates, members, partners, shareholders, directors, officers, employees, consultants, agents or advisors of the Receiving Party who have agreed to comply with the terms of this Agreement and who need to know such Confidential Information in connection with this Agreement.  The Receiving Party further agrees that it will not use the Confidential Information of the Disclosing Party for its own benefit or for the benefit of any third party, in each case, except as expressly permitted in this Agreement.  Without affecting the generality of the foregoing, the Receiving Party agrees that it will exercise no less care to safeguard the Confidential Information acquired from the Disclosing Party than the Receiving Party exercises in safeguarding its own confidential and proprietary information, but in no event, with any less than reasonable care. 

    Confidential Information does not include information that the Receiving Party can prove: (i) was known by the Receiving Party, without restriction, at the time of disclosure by the Disclosing Party, as demonstrated by files in existence at the time of the disclosure; (ii) is or becomes a matter of public knowledge without breach of the Receiving Party’s obligations under this Agreement; (iii) was acquired by the Receiving Party from a third party (other than the Disclosing Party or its representatives) that was lawfully in possession of such information and not in violation of any confidentiality or other contractual or legal obligation to the Disclosing Party with respect to such information; or (iv) is independently developed by the Receiving Party’s members, partners, shareholders, directors, officers, employees, consultants, agents or advisors without reference to the Confidential Information of the Disclosing Party. 

    Notwithstanding the above, the Receiving Party shall not have liability to the Disclosing Party with regard to any disclosure of Confidential Information of the Disclosing Party that the Receiving Party can prove is disclosed by the Receiving Party or its affiliates, members, directors, officers, employees, consultants, agents or advisors pursuant to the order of a court or other government body or as required by law or regulation; provided, however, that the Receiving Party shall (i) to the extent legally permitted, provide written notice to the Disclosing Party reasonably in advance of any such disclosure to allow sufficient opportunity for the Disclosing Party to object to and/or prevent such disclosure, and (ii) cooperate fully with the Disclosing Party in taking legally available steps to prevent or narrow such disclosure, including, without limitation, by seeking a protective order or confidential treatment. 

  8. Recordkeeping. For a period of two years from the date of Customer’s most recent purchase under this Agreement, Customer shall keep and maintain records with respect to the purchase and administration of Products ordered pursuant to this Agreement. Customer shall, upon receipt of a written request from QuVa, furnish such records and information in a mutually acceptable format within thirty (30) days of receipt of such request. QuVa agrees that all records shall be subject to the requirements of state and federal law regarding the confidentiality of medical and prescription records. 

  9. Force Majeure. Other than the obligation to pay money, the obligations to perform under this Agreement shall be excused when caused by acts of God, shortages of power, global pandemics, market condition changes affecting supplies, or government orders or other causes which are beyond the reasonable control of a Party obligated to perform (“Force Majeure Event”). In the event that a Party ceases to perform its obligations under this Agreement due to the occurrence of a Force Majeure Event, such Party shall: (1)  immediately notify the other Party in writing of such Force Majeure Event and its expected duration; and (2) take reasonable steps to recommence performance of its obligations under this Agreement as soon as possible. 

  10. Returns and Recall Management. QuVa does not accept returned Products in the normal course of its business and will only accept Product returns and provide credit in limited circumstances. All Product returns are subject to QuVa’s return of goods policy as in effect at the time of any purchase of Products under this Agreement. For recall management procedures, Customer shall ensure that Customer will be able to track Products received from QuVa and administered to patients per its recall policy. Customer shall promptly notify QuVa if any adverse reactions or complaints regarding the Products are received. If QuVa should recall a Product, Customer will be notified in writing and will handle said recall per Customer’s policy and procedures. The Parties shall cooperate in investigating and resolving such complaints or recalls.  

  11. Governing Law and Venue. This Agreement shall be governed by and construed in accordance with the law of the State of Texas. Any action under this Agreement shall be brought in any court of competent jurisdiction for Fort Bend County, Texas. 

  12. Assignment. A Party may not assign its rights or delegate its duties without the prior written consent of the other, which will not be unreasonably withheld, conditioned or delayed. Notwithstanding the foregoing, QuVa may assign this Agreement without the need for consent to any affiliate or successor entity, whether through conversion, merger or otherwise.  

  13. Non-Waiver. No waiver or failure of a Party to exercise its rights under this Agreement shall be deemed a waiver of any of such Party’s rights. All rights and remedies granted herein are cumulative and any Party’s resort to one shall not preclude its resort to any other right or remedy provided by law. 

  14. Modification or Amendment. This Agreement may be modified or amended only by a written agreement signed by each Party and in the event any provision of this Agreement is found to be unenforceable or invalid, such provision shall be severable from this Agreement and shall not affect the enforceability or validity of any other provision contained in this Agreement.