SMP Nutra Vendor Agreement

SMP NUTRA VENDOR AGREEMENT

Thank you for taking our order! We value your service.

Please note that our purchase order is also subject to the Terms and Conditions of Purchase Orders (“T&C of Purchase Order”), which is also available on our website. Whether you are tendering a deposit payment, partial payment on account, full payment, or electing to use credit terms, you are acknowledging, agreeing to, and accepting the T&C of Purchase Order, whether you sign the acknowledgement below or not. Additionally, unless these T&C of Purchase Order are modified in writing and signed by both parties, the T&C of Purchase Order shall be applicable to this and all future transactions between Company and Customers.

This Agreement (this “Agreement”) is between Supplement Manufacturing Partner Inc., a New York corporation having an address at 1 Rodeo Drive, Edgewood, NY 11717, doing business as “SMP Nutra,” and , a corporation having an address at , doing business as .

WHEREAS SMP Nutra is engaged in the manufacture, distribution, and sale of, among other things, vitamins, dietary supplements, nutritional products, and other healthcare products (the “Products”) to various Customers (as defined below)

WHEREAS Vendor is engaged in the formulation, testing, manufacture, packaging, and distribution of dietary supplements

WHEREAS SMP desires to have Vendor manufacture, package, and supply to SMP the Products from Vendor’s distribution facility under the following terms and conditions (the “Distribution Arrangement”)

WHEREAS, in connection with such Distribution Arrangement, Vendor is in possession of identifying information relating to Customers that Vendor would not otherwise have but for such Distribution Arrangement.

NOW, THEREFORE, in consideration of the premises and mutual agreements hereinafter set forth, the parties hereto, intending to be legally bound, hereby agree as follows:

1.        Definitions.

           1.1 “Act” shall mean the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq., as amended, and regulations promulgated thereunder.

           1.2 “Affiliate” shall mean, with respect to any given Person, (A) any other Person at the time directly or indirectly controlling, controlled by or under common control with that Person, (B) any other Person of which that Person at the time owns or has the right to acquire, directly or indirectly, 10% or more on a consolidated basis of any class of the capital stock or other ownership interest, or (C) any other Person which at the time owns or has the right to acquire, directly or indirectly, 10% or more of any class of the capital stock or other ownership interest of that Person. For purposes of this definition, “control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Person, whether through ownership of voting securities, by contract or otherwise.

           1.3 “Customer” means (i) any Person and any Affiliate thereof, who a customer of SMP Nutra on the date of execution of this Agreement is, who is not currently a customer of Vendor and (ii) any Person and any Affiliate thereof who becomes a customer of SMP Nutra or its Affiliates from the date of execution of this Agreement until the end of the Agreement Term and is not at that time a customer of Vendor.

           1.4 “Facility” means Vendor’s manufacturing facility at , and, such other facilities to be used by Vendor in the manufacture, packaging (including labeling), testing and storage of Products or materials utilized in the manufacture and packaging of Products (including quality control) hereunder.

           1.5 “FDA” shall mean the United States Food and Drug Administration in the Department of Health and Human Services or any successor agency.

           1.6 “Governmental Authority” means any court, tribunal, arbitrator, agency, commission, official or other instrumentality of the United States, Puerto Rico or any U.S. State having lawful jurisdiction over the Products and any court, tribunal, arbitrator, agency, commission, official or other instrumentality of any other country as may be mutually agreed upon in writing by the parties.

           1.7 “Master Documentation” means collectively the Master Batch Records, Master Packaging Records, Master Process Controls, Raw Material Specifications, Packaging Material Specifications, Product (Bulk and Finished) Specifications, Raw Material Test Methods, Packaging Material Test Methods, Product Test Methods, Test Method Validation Reports, Manufacturing Validation Reports, Packaging Validation Reports, Stability Studies supporting Expiration Dating, Cleaning Validation Reports and any other testing or documentation prepared in the ordinary course of business in support of the Product.

           1.8 “Person” shall mean any individual or corporation, limited liability company, partnership, trust, estate, incorporated or unincorporated association, joint venture or other legal entity or organization of any kind.

           1.9 “Price” means the price to be charged by Vendor for each of the Products supplied, as set forth on Exhibit A which may be amended or otherwise modified from time to time pursuant to the terms herein.

           1.10 “Product(s)” means the Products listed in Exhibit A in finished and packaged form which will be manufactured, packaged, and supplied by Vendor. Upon the Parties’ mutual written consent, the Parties may from time to time add to, subtract from, or substitute other Products for the Products listed on Exhibit A.

           1.11 “Quality Agreement” means the quality agreement referenced in Section 2.11 of this Agreement which the Parties agree to simultaneously enter into upon the execution of this Agreement.

           1.12 “Recall”, with respect to any Product, shall mean a “recall”, “correction”, “stock recovery” or “market withdrawal”, as those terms are defined in 21 CFR 7.3, as the same may be amended from time to time, and shall include any post-sale warning or mailing of information regarding such Product, including those warnings or mailings described in 21 CFR 200.5.

           1.13 “Specifications” mean the specifications for the manufacturing, packaging, and labeling of the Products described on Exhibit A to this Agreement. Specifications for each Product are provided in writing by SMP to Vendor by way of attachment to each Purchase Order.

           1.14 “Third Party” means any Person other than Vendor or SMP or either of their related entities or Affiliates.

2. Product Manufacture and Supply.

           2.1 Vendor’s Responsibilities. Vendor shall manufacture and sell Products to SMP on the terms and conditions set forth herein. Vendor shall, at all times, manufacture, produce, and supply Products for SMP which meet and comply with the Specifications, current good manufacturing practices, the requirements set forth in the Quality Agreement, and any other applicable laws or regulations governing Vendor’s business and operations.

           2.2 Supply of Raw Materials. Vendor shall be responsible for ordering, purchasing, testing, and supplying all raw materials necessary for the manufacture of Products at Vendor’s expense. Vendor will store any materials purchased by SMP from Vendor that will be used for SMP Products at no cost to SMP and will store all such materials in accordance with the Quality Agreement. In the event that SMP itself supplies any of the raw materials, components, or bulk Products to be used in the production of SMP Products by Vendor, Vendor will store such materials supplied by SMP at no cost to SMP.

                      2.2.1 Vendor will accept raw materials supplied by SMP for the manufacture of SMP’s Products with the understanding that Vendor is relying completely on the COA provided with the raw materials to determine the content of the raw materials. Vendor shall not be required to conduct additional testing to verify the information stated on the COA. Only at the written request of an officer of SMP, which includes SMP’s agreement to pay all costs associated with such testing, will Vendor test raw materials supplied by SMP.

                      2.2.2 Vendor shall be responsible for inferior, contaminated, or adulterated raw material or mistakes on the COA. All SMP Supplied Raw Materials are subject to a $175 testing fee to pass all cGMP and FDA Requirements.

                      2.2.3 If SMP supplies raw materials, SMP shall supply enough material to manufacture the Product allowing for the overage required in the manufacturing process. Vendor shall not be responsible for shortages if SMP does not supply enough raw materials to complete the project

                      2.2.4 Each order has the possibility of a ten percent (10%) +/- fluctuation for the final quantity of Product. SMP acknowledges that this fluctuation is in accordance with industry standards and SMP is responsible for the cost associated with this fluctuation, regardless of the size of the order or whether the order is for an initial run. SMP will be billed for the full number of bottles manufactured. Vendor will keep three (3) of the bottles, as Vendor is required to keep retainer bottles for Quality Control as per FDA, CGMP Regulations.

           2.3 Forecast. SMP may provide Vendor at each quarter, but not more than four (4) times per year, with a written rolling forecast of estimated monthly purchases of Product for the subsequent twelve (12) months. Such forecasts shall represent SMP’s good faith estimate of its requirements. Such forecasts are for the convenience of Vendor only, shall not constitute firm purchase orders and shall not be binding upon, or create any obligation or liability with respect to, SMP or Vendor. Vendor shall notify SMP within 5 days of receipt of such forecast if Vendor reasonably believes it will be unable to meet SMP's anticipated forecast.

           2.4 Purchase Orders. SMP shall provide Vendor with separate, pre- numbered “Purchase Orders” for all Products. Purchase Orders are deemed accepted unless Vendor notifies SMP of rejection of the Purchase Order two (2) business days from receipt of the Purchase Order. Purchase Orders shall specify quantities of each Product, delivery, and due dates. Unless otherwise stated in a Purchase Order, all shipping will be FOB Edgewood, New York. A separate written Specifications sheet will accompany every Purchase Order. Vendor shall fulfill all SMP purchases as stated in the Purchase Order. SMP shall be obligated to pay Vendor for quantities of Product produced, shipped and released by Vendor in accordance with the terms of SMP’s Purchase Orders and the terms of this Agreement and the Quality Agreement. All invoices, packing slips, and bills of lading must reference the associated Purchase Order number.

                      2.4.1 All orders are to be manufactured by Vendor. Acceptance of the Purchase Order by Vendor will serve as confirmation of the quantities, Price, received date, and shipping terms. SMP shall be obligated to buy, and Vendor shall be obligated to sell, only those Products that are subject to a Purchase Order accepted by Vendor. All shipments will include a Certificate of Analysis (“COA”) to be emailed to SMP by Vendor at the time of shipping or included with the shipment. Any defective goods shall be returned at Vendor’s expense and a full credit shall be issued to SMP. Materially incomplete Purchase Orders (more than 20% shortfall) will incur an undercount fee of 5%. Purchase Orders that are more than thirty days late will incur a Liquidated Damages Fee of 2% of the cost of goods stated on the accepted Purchase Order for each day late past 30 days, up to a maximum of 50%. If a Purchase Order is more than sixty days late, Vendor shall be entitled to cancel the order and to receive a credit (towards future orders) or payment (at SMP’s option) in an amount equal to 50% of the Purchase Order. The parties agree that reputational damages and lost future orders caused by late delivery of Purchase Orders are difficult to calculate, and that the above fees are a reasonable calculation of SMP’s damages in the event that a shipment is more than sixty days late. Goods shipped without a COA and/or packing slip shall incur a penalty fee of one hundred dollars per day ($100.00 up to and until a COA and/or packing slip is received by SMP).

                      2.4.2 In the event SMP seeks to modify a Purchase Order which has been confirmed by Vendor, SMP and Vendor will use reasonable commercial efforts to accommodate SMP’s needs. If SMP requires decreases in Production volumes of a confirmed Purchase Order, SMP shall be responsible for the cost of materials for the Product purchased by Vendor in excess of the requirements necessary to fulfill SMP’s decreased Purchase Orders; provided, however, SMP shall not be responsible for the cost of any materials that are or will be subsequently used by Vendor within the next one hundred and eighty (180) days. Vendor will provide the invoice from Vendor’s materials vendor to SMP for any materials that SMP is responsible to purchase from Vendor. If Vendor incurs any additional costs as a result of the modification of a Purchase Order by SMP, SMP shall reimburse such costs.

                      2.4.3 Vendor will provide a monthly report of any inventory (including raw materials, work-in-process and/or finished Product) owned by SMP held by Vendor no later than the fifth (5th) business day of each month with an explanation of any variances greater than two percent (2%). In addition, SMP shall have the right to audit such inventory.

                      2.4.4 Vendor shall guarantee and ensure that all SMP purchase requirements, as set forth in a Purchase Order, this Agreement, or the Quality Agreement, are met against confirmed Purchase Orders. Should Vendor be unable to meet the requirements of a confirmed Purchase Order, Vendor shall either:

(a) Allow SMP to source Products from a third party for the period upon which Vendor is unable to supply in accordance with confirmed Purchase Orders. Vendor will assume all incremental costs associated with this activity including set up and development costs and the differential (if any) between the Vendor pricing and the pricing of the third-party manufacturer; or

(b) Seek out a third-party manufacturer, approved by Vendor, to supplement the manufacturing of the Products to meet all SMP requirements. Vendor will assume all incremental costs associated with this activity including set up and development costs and the differential (if any) between the Vendor pricing and the pricing of the third-party manufacturer.

           2.5 Price, Invoices, Price Adjustments, and Cost Improvement.

                      2.5.1 SMP shall pay Vendor for Products purchased pursuant to this Agreement in accordance with Exhibit B of this Agreement, which may be adjusted from time to time by mutual agreement of the Parties. In no event, however, shall Vendor increase the Price of the Products more than twice in any twelve (12) month period and must be approved in writing by SMP. Increases in the Prices reflected in Exhibit B shall become effective after thirty (30) days advance written notice. All Purchase Orders previously accepted by Vendor shall remain at the price quoted at the time of the Purchase Order’s issue. SMP shall make payment for all deliveries of Product in U.S. dollars, net thirty (30) days. SMP shall receive a discount of 2% as agreed upon by SMP and Vendor for any payments made at least twenty (20) days earlier than net thirty (30) days. Vendor shall provide invoices dated as of the date the Product is shipped from Vendor or placed in storage with notification to SMP’s quality department. Invoices shall be sent to SMP Nutra, Inc., ATTN: Purchasing Dept., or to such other persons, departments, or locations as SMP may instruct from time to time.

                      2.5.2 The Prices listed in Exhibit B are inclusive of all taxes, duties, or other assessments.

                      2.5.3 SMP shall have fourteen (14) business days from the time of delivery to inspect all shipments for accuracy and damages. Should any portion of the shipment be damaged, SMP shall notify the Vendor in writing and Vendor shall have an additional fourteen (14) business days to provide new Product or issue SMP a credit for damaged goods.

           2.6 Modification of Specifications. The Specifications are provided to Vendor by SMP by way of written documentation accompanying each Purchase Order. The Specifications may be modified or changed only if approved in writing by SMP. To the extent that such modification or change results in an increase or decrease in the cost of manufacturing any Product or requires additional capital investment, the Parties shall jointly examine and mutually agree in writing upon the consequences thereof, including changes to expected or requirement delivery times or cancelation of the existing Purchase Order. In the event that the Vendor does not follow the specifications as provided by SMP and without written approval of a necessary change, there will be a penalty of $500 per modification to either be credited or paid to SMP.

           2.7 Purchases of Labels, Manufacturing of Labels, Packaging of Products.

                      2.7.1 SMP shall provide Specifications (including art proofs) for packaging and labeling. Vendor shall purchase at its own expense labels for use on SMP Products solely from a label printer previously approved in writing by SMP. Prior to purchasing any labels, Vendor shall contact the SMP Purchasing Dept. at (833) 810-9896 to ensure Vendor receives the best possible label prices. In the event Vendor wishes to self-print labels for SMP Products, Vendor shall submit physical samples of labels to SMP’s Senior Graphic Artist-Label Specialist, for approval; and Vendor shall not label or package any SMP Product using any label or packaging not approved by SMP in advance of such labeling or packaging. Vendor must obtain the most current artwork from SMP’s Senior Graphic Artist-Label Specialist and notify SMP of any label price changes which affect the finished good cost on each Purchase Order.

                      2.7.2. Vendor shall package all Products in case lots/case quantities. All cases must include box labels indicating the Product name, a Product code number, lot number, manufactured on, expiration, or best-by date, Purchase Order number, allergens, and Product quantity. Packaging configurations shall not exceed 8.5″ high x 5.5” wide (no restriction on length). Pallets of single Product shall not to exceed 48″ in height. Product package weight shall not exceed 50 lbs. If a shipment contains fulfillment of multiple Purchase Orders, adequate labeling and dividers must be used by Vendor to ensure SMP can adequately distinguish each separate Purchase Order upon receipt. If multiple boxes or pallets are used, Vendor must sequentially number each box or pallet. Vendor shall include a Product packing list with each Product shipment.

                      2.7.3 A Product’s expiration can only be properly determined by conducting a stability study. In the event SMP does not provide the results of a stability study, the Product will be issued a “manufactured on” date. If SMP requests a specific expiration date be affixed to the Product, it is certifying that the Product and packaging ordered has been stability tested in accordance with industry standards prior to placing the order and that the Product and packaging specifications provided by SMP are identical to the specification used for stability testing. Vendor is not responsible for stability testing the Product.

           2.8 Storage Requirements. Vendor shall store all materials and Products in accordance with the Specifications, cGMPs, and requirements set forth in the Quality Agreement.

           2.9 Nonconforming Materials. Vendor shall not use any packaging or other Product materials that do not comply with the Specifications, cGMPs, requirements set forth in the Quality Agreement, or applicable laws, rules, or regulations. Vendor shall promptly contact SMP, c/o Quality Department (at the address specified in Section 12) in the event that Vendor anticipates making changes to any such material or in the event Vendor considers any such material to be nonconforming or unacceptable. If Vendor uses any non-conforming Product material without prior written approval by SMP, Vendor shall be responsible for all losses, costs and expenses suffered or incurred by SMP as a result of such use and any expenses incurred by Vendor in the correction thereof.

           2.10 Rejection of Products/Latent Defects. SMP shall have the right to give Vendor written notice of rejection of any shipment of Product that in whole or in part breaches Vendor’s warranties, covenants and obligations under this Agreement or fails to comply with the requirements set forth in the Quality Agreement, which notice shall be given promptly, and in any event within (thirty) 30 days, after discovery of such breach. If there is disagreement between the Parties as to whether the Product meets Specifications, the Parties shall have such Product tested by a mutually agreed upon third party and such Party’s determination as to whether such Product meets Specifications shall be binding on the Parties hereto. The expense for such testing and for any costs associated with the destruction of such Product shall be borne by SMP except to the extent it is determined that Vendor is responsible for such failure or breach. At SMP’s option, Vendor shall immediately replace Product which does not conform with Vendor’s warranties under this Agreement considering SMP’s production schedule as communicated to Vendor. SMP shall have the right to set off any refund due SMP on account of rejected Product against invoices otherwise due or which become due to Vendor. The provisions of this Section 2.10 shall survive termination of this Agreement with respect to Products supplied by Vendor and prior to any last sale date on the Product label. Subsequent to the termination or expiration of this Agreement, SMP, in lieu of having Vendor replace such rejected Products, may elect to have Vendor reimburse SMP for the purchase Price actually paid for such Products.

           2.11 Quality Agreement. The Parties shall enter into the Quality Agreement simultaneously with the execution of this Agreement in furtherance of the terms, conditions, and provisions of this Agreement. The provisions of the Quality Agreement, and its exhibits and attachments, are incorporated herein by reference.

           2.12 Purchase and Installation of Equipment. Vendor shall be responsible for purchasing, installing, qualifying, and maintaining at its Facility any and all new or used equipment necessary for the manufacturing, packaging, labeling, testing, holding, storage, and shipment of Products hereunder. All costs and expenses associated with such purchase, installation, qualification, and maintenance shall be borne by Vendor. The installation, qualification and maintenance of all equipment shall be conducted in accordance with requirements set forth in the Quality Agreement, applicable laws, current good manufacturing practices, rules and regulations and any relevant Specifications.

           2.13 Standard Forms. In ordering and delivering Products, SMP and Vendor may employ their standard forms, but nothing in those forms shall be construed to modify or amend the terms of this Agreement, and, in the case of any conflict herewith, the terms of this Agreement shall control.

           2.14 Legal and Regulatory Filings and Requests. Vendor and SMP shall cooperate and be diligent in responding to all requests for information from, and in making all required filings with, any Governmental Authority having jurisdiction to make such requests or require such filings. Vendor shall obtain and comply with all licenses, consents, permits and regulations which may from time to time be required by appropriate Governmental Authorities with respect to the performance of its obligations hereunder. Vendor and SMP agree to supply each other with copies of all regulatory filings directly or indirectly applicable to the Products.

           2.15 Risk of Loss. All Product sold to SMP pursuant to this Agreement shall remain the property of Vendor, who shall assume all risk of loss until: (1) delivered with appropriate documentation to SMP, F.O.B. SMP, 1 Rodeo Drive, Edgewood, NY 11717, and shipped in pallets to the warehouse of SMP’s choice, paying freight, or (2) picked up by SMP at Vendor’s facility at a scheduled time within 72 hours of Product completion. Any damage to Products while in the possession of Vendor or a third-party shipping company is the sole responsibility of Vendor.

           2.16 Shipping. SMP will provide a listing of carriers and all freight charges associated with the movement of Product from Vendor to SMP shall be on the account of SMP unless otherwise agreed in advance by the Parties. Vendor will schedule freight pick up, load the carrier’s trailer, and complete documentation. Any claims relating to quantity, weight and loss or damage to any Product sold under this Agreement shall be waived by SMP unless made within ninety (90) days of receipt of Product by SMP or SMP’s designee. Delivery of Products shall be on slip sheets and pallets or as otherwise instructed by SMP and agreed to by Vendor.

3. Representations and Warranties; Additional Covenants.

           3.1 General Representations and Warranties. Vendor hereby represents, warrants and covenants to SMP that Products furnished by Vendor to SMP pursuant to this Agreement: (i) shall be of the quality specified in, and shall conform with, the Specifications; (ii) shall be manufactured, held, processed, and packaged (including labeling), stored and delivered in conformity with the Specifications, the Quality Agreement, and all applicable laws, rules and regulations imposed by any Governmental Authority, including current good manufacturing practices as set forth in 21 C.F.R. Parts 111 and 117 and the requirements of the Safe Drinking Water and Toxic Enforcement Act of 1986, codified at California Health and Safety Code Section 25249.5 et seq. (Prop 65);(iii) shall not contain any material provided by or on behalf of Vendor, which material has not been used or stored in accordance with the Specifications or in violation of the Quality Agreement, or any other quality assurance standards instructed by SMP and agreed to by Vendor; (iv) will not contain any material(s) that would cause the Products to be adulterated or misbranded within the meaning of the Act, provided, however that with respect to any labeling approved and directed to be placed on Products by SMP, Vendor shall not bear responsibility for such labeling.

           3.2 Compliance with Laws. Vendor represents, warrants and covenants that as of the date of execution of this Agreement (i) Vendor is and shall continue to be, in full compliance with all applicable laws, rules and regulations including all applicable labor and employment laws and environmental laws and all other laws imposed by any Governmental Authority which Vendor is subject to; and (ii) Vendor holds all licenses, permits, and similar governmental authorizations necessary or required for Vendor to conduct its operations and business and perform this Agreement and the Quality Agreement. All references in this Agreement to applicable laws, rules and regulations shall include all current good manufacturing practices, as set forth in the Quality Agreement.

           3.3 Notice of Material Events. Vendor hereby agrees to notify SMP promptly of any actual or anticipated events which are reasonably likely to have a material adverse effect on the Products or on Vendor’s ability to produce Products in accordance with the provisions set forth herein, including, but not limited to, any fire or natural disaster, customs detention, labor difficulties, strikes, shortages in materials, notices of regulatory inspections or deficiencies, plant closings and other interruptions in activity. The requirements of this Section are in addition to those set forth in the Quality Agreement with respect to changes to the manufacturing process that may impact the quality of any Product.

           3.4 Disclaimers. SMP AND VENDOR MAKE NO WARRANTIES WITH RESPECT TO THE PRODUCTS, LABELING OR PACKAGING, EXPRESS OR IMPLIED, EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED.

           3.5 SMP Product Warranties. SMP represents, warrants, and covenants that performance of this Agreement by Vendor in accordance with the Specifications will not breach any material law, rule, or regulation or, to the best of SMP’s knowledge, infringe any intellectual property rights of any third parties.

           3.6 Remedies. Without limiting any other remedy, Vendor will replace any defective Products if notice is given as provided in Section 2.10; provided, however, that a Product shall not be considered defective to the extent the Product conforms to the Specifications (including meeting the expiry period) at the time Vendor ships the Products.

4. Ownership; Trademarks; Proprietary Information.

           4.1 Ownership of Intellectual Property.

                      (a) It is agreed that SMP or its Customers are the sole owner of the Products and any and all Specifications, and Vendor shall not use any such Specifications except in connection with its performance under this Agreement or the Quality Agreement.

                      (b) Any trademarks, trade names, trade dress, trade secrets, licenses, brand names, patents, patent applications, statutory invention registrations, inventor’s certificates, rights to obtain, file, and prosecute applications for patents, slogans, logos, copyrights, Specifications, or other property or proprietary information and goodwill associated with the Products shall be the sole and exclusive property of SMP or its Customers (the “Product Intellectual Property”). Vendor shall have no right or license to use any such Product Intellectual Property at any time before, during or after the Term of this Agreement, except as necessary for Vendor to comply with its obligations under the terms of this Agreement or the Quality Agreement.

                      (c) If any improvements or modifications to the Products or Specifications are developed by SMP or Vendor, either jointly or severally, such improvements or modifications shall inure to the benefit and be the exclusive property of SMP and shall be held in confidence by Vendor for SMP’s sole benefit in the development and/or the operation of manufacturing processes with respect to the Products. Vendor shall disclose to SMP and receive the approval of SMP with respect to all such improvements or modifications relating to the manufacturing, and/or packaging process of the Products or use of the Products developed by Vendor.

           4.2 Ownership of Other Property. Except as otherwise specified herein or agreed in writing, the Vendor is the sole owner of any-and-all equipment, tools, dies, molds, printing plates, etc. used by Vendor in connection with the manufacture and packaging of the Products in accordance with this Agreement. Vendor shall maintain the above in good working order and shall ensure that they remain free and clear of all liens and encumbrances that would impair their use under this Agreement. The processes adopted and employed by Vendor and not provided by SMP in producing Product shall be the property and sole responsibility of Vendor unless otherwise agreed in writing.

           4.3 Reproduction of Trademarks, Etc. In connection with Vendor’s performance of this Agreement, SMP hereby grants Vendor the right to reproduce and print on the Products, if applicable, SMP or Customer trademarks, trade dress and/or trade names of such Products which SMP may designate in writing from time to time, in accordance with trademark usage guidelines set forth in the Specifications or otherwise provided by SMP. Vendor shall submit samples of all such uses of such trademarks and/or trade names on the Products or Product packaging to SMP for its written approval prior to production. The permission granted herein is restricted to the Products supplied under this Agreement and extends only for the Term of this Agreement.

           4.4 SMP’s Limited Rights to Use. Nothing set forth in this Agreement shall be construed to grant to SMP any title, right or interest in or to any trademark, trade name, copyright, patent, or other proprietary technology owned by Vendor, or any of its Affiliates, or to which Vendor, or any of its Affiliates may have rights.

SMP’s use of such trademarks, trade names, copyrights, patents, or other proprietary technology shall be limited exclusively to its performance of this Agreement. Any other use of said trademarks, trade names, copyrights, patents, or other proprietary technology shall constitute an infringement thereof and/or violation of Vendor’s rights. Notwithstanding the foregoing, with the prior written approval of Vendor which shall not be unreasonably withheld, SMP shall be permitted to use Vendor’s name and trademarks in connection with general advertising and promotional activities.

           4.5 Vendor’s Manufacture of Other Products. Any technology or information owned by SMP and provided by SMP to Vendor in connection with this Agreement shall not be used by Vendor in the manufacture of any products other than the Products and shall not be disclosed or made available to any customers of Vendor or any third party. All such information shall be deemed Proprietary Information subject to the provisions of Section 8 of this Agreement.

5. Indemnification.

           5.1 Vendor’s Indemnification of SMP. Vendor shall indemnify, defend and hold SMP, each Affiliate of SMP and the officers, employees, and agents thereof (each an “SMP Indemnified Party”) harmless from and against any and all losses, liabilities, damages, claims, expenses, suits, recoveries, judgments and fines (including reasonable attorneys’ fees and expenses) (collectively, “Losses”) that may be incurred by any SMP Indemnified Party arising out of the Manufacture Arrangement or the Distribution Arrangement, including without limitation (i) for claims that any Product is not manufactured in accordance with industry standards or not manufactured in accordance with customer specifications (in addition to the right of SMP Nutra to indemnification hereunder, SMP Nutra shall have the right from time to time to set off any Losses against any payments due and payable to Vendor pursuant to the Distribution Arrangement); (ii) any profits or Customers lost by SMP Nutra, arising out of or relating to breaches of this Agreement, the T&C of Purchase Order, Distribution Arrangement, or Quality Agreement, by Vendor, and for any reputational damages arising therefrom; (iii) any damage to property or injury or death occurring to any Person arising out of possession, use or consumption by any Person of any Product to the extent that such damage, injury or death was caused by the failure of such Product to meet Specifications, including the contamination, adulteration, or misbranding of such Product which occurred prior to the time such Product came under the control of SMP; (iv) any damage to property occurring on Vendor’s premises or injury to person or death occurring to any Vendor employees, subcontractors, agents or any individuals at Vendor’s Facility or otherwise on Vendor’s premises; (v) any claim, action or proceeding brought by any Governmental Authority arising out of or resulting from any manufacture, packaging, holding, labeling, or supply (including quality control requirements set forth in the Quality Agreement) of Products by Vendor which is not in accordance with this Agreement or the Quality Agreement; (vi) any breach by Vendor of any of its obligations, representations or warranties under this Agreement or the Quality Agreement, including a breach which results in a recall of Products to the extent that Vendor is responsible for such recall; (vii) any claim by a third party that the methods, processes, Product component materials or know-how not provided by SMP infringe the ownership rights of a third party; or (viii) any other act or omission on the part of Vendor constituting negligence. The provisions of this Section 5 shall survive the expiration or earlier termination of this Agreement. All existing products manufactured before this agreement date, by Vendor for SMP or its affiliates are excluded from the provisions of this agreement.

           5.2 SMP’s Indemnification of Vendor. SMP shall indemnify, defend and hold Vendor, each Affiliate of Vendor and the officers, directors and employees thereof (each a “Vendor Indemnified Party”) harmless from and against any and all Losses that may be incurred by any Vendor Indemnified Party arising out of (i) any damage to property or injury or death occurring to any person arising out of possession, use or consumption by any person of any Product to the extent that such damage, injury or death was caused by the contamination, adulteration or misbranding of such Product which occurred when such Product was under the control of SMP or by any defective Specification furnished by SMP, raw materials supplied by SMP, or stability testing performed by SMP; (ii) any claim that the manufacture of any Product by Vendor under this Agreement infringes the trademark, trade dress, trade secret or other intellectual property rights of any other Person solely by reason of the use of such intellectual property by SMP in the specifications, packaging or labeling of the Product; (iii) any breach by SMP of any of its obligations, representations or warranties under this Agreement, including a breach which results in a Recall of Products or (iv) any other act or omission on the part of SMP constituting negligence. In the event that testing of the finished Product reveals that the Product does not meet specifications due to raw materials supplied by SMP, SMP will hold Vendor harmless and assume all liability and costs associated with the manufacturing of the Product. If SMP’s packaging and/or Product specifications have not been stability tested, or the specifications provided to Vendor deviate from those used in the stability test, SMP agrees to hold Vendor harmless and indemnify fully the Vendor against any and all claims for damages or loss arising out of the Product becoming unstable, unmarketable, less effective than claimed or intended, or otherwise deviating from the Specifications, which occurred as a result of the Product’s instability after manufacturing.

           5.3 Indemnification Procedures.

                      5.3. Any Person that may be entitled to indemnification under this Agreement (an “Indemnified Party”) shall give written notice to the Person obligated to indemnify it (an “Indemnifying Party”) with reasonable promptness upon becoming aware of any claim against such Indemnified Party by a third party or other facts upon which a claim for indemnification will or is reasonably likely to be based, but the failure to notify, or delay in notifying, the Indemnifying Party will not relieve the Indemnifying Party of any liability it may have to any Indemnified Party except to the extent that the Indemnifying Party demonstrates that it is prejudiced by the Indemnified Party’s failure to give, or delay in giving, such notice. The notice shall set forth such information with respect thereto as is then reasonably available to the Indemnified Party. The Indemnifying Party shall have the right to participate in the defense of any proceeding involving a claim asserted by a third party and (unless the Indemnifying Party is also a party to such proceeding and the Indemnified Party determines in good faith that joint representation would be inappropriate) to undertake the defense of any such proceeding with counsel reasonably satisfactory to the Indemnified Party and the Indemnified Party shall cooperate in such defense and make available all records, materials and witnesses reasonably requested by the Indemnifying Party in connection therewith at the Indemnifying Party’s expense. If and so long as the Indemnifying Party shall have assumed the defense of such proceeding with counsel reasonably satisfactory to the Indemnified Party and is diligently conducting such defense, the Indemnifying Party shall not be liable to the Indemnified Party for any legal or other expenses (other than for reasonable costs of investigation) subsequently incurred by the Indemnified Party in connection with the defense thereof, but the Indemnified Party shall have the right to participate in the defense of such proceeding at its own expense. If the Indemnifying Party so assumes the defense of a proceeding involving a third-party claim, it will be conclusively established for purposes of this Agreement that such claim is within the scope of and subject to indemnification.

                      5.3.2 Notwithstanding the foregoing, if SMP is the Indemnified Party and it determines in good faith that there is a reasonable probability that a proceeding involving a third-party claim would materially harm the reputational or other value of the brand of the relevant Products, then SMP may, by notice to the Vendor, assume the exclusive right to defend, compromise or settle such proceeding.

                      5.3.3 The Indemnifying Party shall not be liable for any third-party claim settled without its consent, which consent shall not be unreasonably withheld or delayed. The Indemnifying Party shall obtain the written consent of the Indemnified Party prior to ceasing to defend, settling, or otherwise disposing of any third-party claim.

                      5.3.4 In no event shall either Party institute, settle or otherwise resolve any claim or potential claim, action or proceeding relating to the Products or any trademarks or other intellectual property rights of the other Party without the prior written consent of such other Party.

            5.4 Limitation of Liability. Neither Party shall have any liability under this Section 5 or otherwise for any indirect, special, punitive, or consequential damages or losses, such as loss of profits or goodwill, which may be sustained by the other Party hereto as a result of activities under this Agreement, except to the extent such damages have been recovered from the Indemnified Party by a third party.

6. Insurance.

           6.1 Vendor Coverage. Vendor shall acquire and maintain insurance at its sole cost and expense with insurance companies with an A.M. Best rating no lower than A- (A-Minus) including (i) Statutory Worker’s Compensation Insurance and Employer’s Liability Insurance; (ii) all risk coverage for physical loss or damage to materials while at the Facility or under its control; and (iii) Products Liability (with a Broad Form Vendor’s Endorsement naming SMP, its subsidiaries and Affiliated companies and officers, directors, employees and agents of all of them, as well as its authorized distributors as additional insured parties) with a combined single limit of not less than $4,000,000, (iv) Bodily Injury and Property Damage Insurance (with a Broad Form Vendor’s Endorsement naming SMP, its subsidiaries and Affiliated companies and the officers, directors, employees and agents of all of them, as well as its authorized distributors as additional insured parties) with a combined single limit of not less than $2,000,000, and (v) General Liability Insurance of not less than $5,000,000 (with a Broad Form Vendor’s Endorsement naming SMP, its subsidiaries and Affiliated companies and the officers, directors, employees and agents of all of them, as well as its authorized distributors as additional insured parties). Vendor shall use its commercially reasonable best efforts to require its subcontractors, to the extent approved hereunder, to provide the coverages in an amount equal to the lesser of their respective contract costs or $4,000,000.

           6.2 SMP Coverage. SMP shall acquire and maintain at its sole cost and expense with nationally recognized insurance companies reasonably acceptable to Vendor (i) Products Liability with a combined single limit of not less than $4,000,000; and (ii) Bodily Injury and Property Damage Insurance with a combined single limit of not less than $2,000,000.

7. Relationship of the Parties.

           The relationship between SMP and Vendor is that of independent contractors and nothing herein shall be deemed to constitute the relationship of partners, joint venturers, nor of principal and agent between SMP and Vendor. Neither Party shall have any expressed or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any third party. Except as otherwise contemplated or permitted by the Agreement, all persons employed by Vendor in connection with the manufacturing, packaging (including labeling) and supply (including quality control) of the Products to SMP shall be employees or agents of Vendor and under no circumstances shall Vendor or any of its employees or agents be deemed to be employees or agents of SMP.

8. Proprietary Information.

           8.1 As a result of the Distribution Arrangement, Vendor has and will receive certain proprietary information and confidential records developed and compiled by SMP Nutra that have great value to SMP Nutra’s business (the “Proprietary Information”). Proprietary Information includes all information that has or could have commercial value or other utility in the business in which SMP Nutra was engaged or contemplated engaging prior to the date of this Agreement, and all information the unauthorized use or disclosure of which could be detrimental to the interests of SMP Nutra, whether or not that information was specifically labeled as confidential or proprietary by SMP Nutra. By way of example, Proprietary Information includes, without limitation, the following:

                      8.1.1 the name, address and phone number of any Customer, vendor, or Affiliate of SMP Nutra, or any information concerning the transactions, orders, products, prices, strategies, or formulas of any Customer, vendor, or Affiliate of SMP Nutra.

                      8.1.2 any information concerning any product, technology, or procedure employed by SMP Nutra but not generally known to its customers, vendors, competitors or the public;

                      8.1.3 any information relating to SMP Nutra’s pricing or marketing methods, sales margins, cost of goods, cost of material, capital structure, or operating results;

                      8.1.4 any information that is generally treated as confidential or proprietary in any line of business engaged in by SMP Nutra;

                      8.1.5 all materials relating to or embodying any of the foregoing, whether in a handwritten, printed, graphic, video, audio, electronic or other medium.

           8.2 Vendor agrees that it will:

                      8.2.1 use such Proprietary Information obtained from SMP only in connection with the activities to be undertaken in this Agreement and under the Quality Agreement;

                      8.2.2 restrict disclosure of such Proprietary Information within its own organization to only those employees having a reasonable need to know such Proprietary Information; and

                      8.2.3 not divulge to third parties, without the prior written consent of SMP, any Proprietary Information obtained from SMP, particularly as it relates to the transfer of any manufacturing or distribution arrangements with third party vendors or subcontractors, until such time that any current third-party vendor is notified by SMP of such transfer of production to Vendor.

                      8.2.4 protect such Proprietary Information from unauthorized use, access, or disclosure with the same degree of care, but no less than a reasonable degree of care, as it uses to protect its own Proprietary Information.

           8.3 Vendor acknowledges and agrees that SMP Nutra disclosed to Vendor, and entrusted Vendor with, Proprietary Information, and that that Proprietary Information is the exclusive property of SMP Nutra and its Customers. During the Agreement Term or thereafter, Vendor shall not, directly, or indirectly, misappropriate, use, make available, sell, convey, license, or disclose Proprietary Information, except as expressly permitted by this Agreement, or otherwise communicate any Proprietary Information to any Person.

           8.4 The foregoing confidentiality obligations shall not apply if and to the extent that:

                      8.4.1 the Proprietary Information is known to the receiving Party prior to obtaining the same from the disclosing party, as properly demonstrated by the receiving Party’s written records;

                      8.4.2 the Proprietary Information is, at the time of disclosure, in the public domain, or comes into the public domain without any fault of the receiving Party or its Affiliates; provided, however, that Customer names, Customer contact information, pricing, and formulas shall be deemed Proprietary Information, even if such information is publicly searchable or belongs to a Customer). Vendor acknowledges that information that is not novel or copyrighted or patented may nonetheless be Proprietary Information; or

                      8.4.3 the Proprietary Information is obtained by the receiving Party from a third party who is not obligated to keep the Proprietary Information confidential.

           8.5 Upon expiration or termination of this Agreement, each Party shall return to the other Party all Proprietary Information received from the other Party, except for one copy that may be retained for purposes of compliance with the terms of this Agreement and applicable law. The provisions of this Section 8 shall survive the termination or expiration of this Agreement and for a period of eight (8) years thereafter.

           8.6 Vendor agrees not to use or refer to SMP’s name or this Agreement or the Quality Agreement in any public statements, whether oral or written, including but not limited to, annual reports or shareholder reports, general advertising and promotional activities, statements to other customers or prospective customers or other communications, without SMP’s prior written consent, which consent shall not be unreasonably withheld.

9. No Competition.

           9.1 From the date of this Agreement until two years from the date on which Vendor no longer manufactures any Products for SMP Nutra (the “Agreement Term”), Vendor may not directly or indirectly (other than for the benefit of, and at the direction of, SMP Nutra or any affiliate of SMP Nutra (“Affiliate”)) do or attempt to do business with or solicit orders from any Person or entity that is known to be a Customer or prospective Customer of SMP Nutra, nationwide, or otherwise divert or attempt to divert known Customers or prospective Customers for Vendor’s or a third party’s benefit, with respect to any Product previously, now, or at any time hereafter sold or otherwise offered by SMP Nutra or any Affiliate thereof.

10. Non-Solicitation

           10.1 Vendor agrees not to solicit and hire, without SMP’s prior written approval, during the term of this Agreement and for five years thereafter, any SMP employee that directly provided services to Vendor during the term of this Agreement. If Vendor solicits and subsequently hires one of SMP’s employees without prior written approval, then Vendor shall immediately pay SMP thirty thousand ($30,000) dollars to offset SMP’s cost of hiring and training a replacement. In the event consent is given, Vendor will owe a one-time Fee to SMP of ten thousand ($10,000.00) dollars. If a SMP employee voluntarily leaves SMP and contacts Vendor to pursue employment, without any solicitation by Vendor, then no Fee shall be due even if Vendor subsequently hires the employee.

11. Term and Termination.

           11.1 Term. This Agreement shall become effective when first executed by both Parties and shall remain in force for two (2) years subject to the provisions of this Section 9 (the “Term”). After the initial Term, this Agreement shall automatically renew for additional terms of one (1) year unless either Party has provided the other with ninety (90) days prior written notice of intention to terminate.

           11.2 Termination for Breach. Either Party may terminate this Agreement by written notice to the other Party if:

                      11.2.1 the other Party fails to comply with any material term of this Agreement, the Quality Agreement, or breaches any representation or warranty herein and fails to cure such noncompliance or breach within sixty (60) days, including in the case of Vendor’s failure to timely deliver Product in accordance with this Agreement after receipt of written notice thereof.

                      11.2.2 the other Party is dissolved or liquidated, files or has filed against it a petition under any bankruptcy or insolvency law, makes an assignment to the benefit of its creditors, has a receiver appointed for all or substantially all of its property, or has a petition under any bankruptcy or insolvency law filed against it which is not dismissed within sixty (60) days. Such rights of termination shall be in addition to any other remedy a non- defaulting Party may have at law or in equity due to the other Party’s breach of its obligations hereunder.

           11.3 Termination by SMP. SMP may terminate this Agreement at any time by written notice to the Vendor, if:

                      11.3.1 Vendor’s Facility fails to comply with the terms of the Quality Agreement, cGMP requirements in the manufacturing, packaging and storage of the Products and Vendor fails to cure such noncompliance or breach within thirty (30) days after receipt of written notice thereof from SMP, FDA or other Governmental Authority,

                      11.3.2 the continued distribution and sale of Product becomes commercially impractical as a consequence of changes in regulatory requirements, lack of consumer demand, scarcity of required ingredients or other similar circumstances.

                      11.3.3 in the case of a breach of Sections 8 or 9, or

                      11.3.4 at any time and for any reason whatsoever, in SMP’s sole discretion, with ninety (90) days written notice to Vendor.

           11.4 Effect of Termination. Termination of this Agreement, however, shall not affect any obligation to pay money, indemnify, reimburse, maintain confidentiality or otherwise which either Party hereto may have incurred during the Term hereof.

           11.5 Unused Materials. Within ninety (90) days of the effective date of the expiration, termination, or early termination of this Agreement, SMP shall purchase at Vendor’s cost any Product ingredients or component materials (bottles and labels) that Vendor has purchased exclusively for use to manufacturer Product for SMP in accordance with this Agreement. SMP shall not be obligated to purchase any quantities of Product ingredients or materials or Products under this Section

           10.5 which are in excess of that for which SMP has issued a Purchase Order. For the avoidance of doubt, any excess Product ingredients, or materials which Vendor purchases to cover normal scrap/waste in the production of Products is for Vendor’s account as SMP has already paid for such materials in the price of the Products. If Vendor and SMP have previously agreed in writing that Vendor should purchase any Product materials or produce any Product in excess of that which would be required to fulfill SMP’s Purchase Orders, then SMP shall be responsible for such inventory under this Section 10.5. At its option SMP may, in lieu of purchasing such materials at cost, place orders with Vendor for additional Products under the terms of this Agreement in order to extinguish existing stocks of such materials.

           11.6 Return of Products and Materials Supplied by SMP. Upon the effective date of expiration or termination of this Agreement for any reason whatsoever and after fulfilling its obligations under Section 10.5, Vendor shall immediately deliver to SMP or its designee all Products, Specifications, artwork, all Product materials purchased by SMP and all other materials, supplies or equipment provided by SMP. Vendor shall also deliver to SMP or its designee all Products produced hereunder and shall invoice SMP in accordance with the terms of this Agreement.

           11.7 Access to Master Documentation. Upon the expiration or termination of this Agreement, Vendor shall make available to SMP all documentation including Master Documentation relating to the production of Product and prepared in the ordinary course of business during the Term of this Agreement.

12. Acknowledgement; Remedies; Audit; Liquidated Damages.

           12.1 Vendor acknowledges that the provisions of this Agreement are reasonable and necessary for the protection of SMP.

           12.2 Vendor acknowledges that violation of any of its obligations under this Agreement would cause SMP irreparable damage and agrees that SMP’s remedies at law for a breach or threatened breach of any of the provisions of this Agreement would be inadequate and difficult to ascertain, and in recognition of this fact, in the event of a breach or threatened breach by Vendor of any of the provisions of this Agreement, in addition to the remedies at law or in equity or otherwise provided for in this Agreement or otherwise available to SMP, SMP will be entitled to seek equitable relief in the form of specific performance, a temporary restraining order, temporary or permanent injunction, or any other equitable remedy that may then be available for the purposes of restraining Vendor from any actual or threatened breach of its obligations. Without limiting the generality of the foregoing, if Vendor breaches Section 9, hereof, the breach will entitle SMP Nutra to the exclusive remedy of triple the profit from any sales made in violation of Section 9. Given the damage to SMP Nutra’s relationship with the Customer likely to be caused by such a direct solicitation, Vendor agrees that treble damages are a fair and reasonable projection of SMP Nutra’s future damages, including attorney’s fees and costs. If Vendor breaches Section 8, hereof, that breach will entitle SMP Nutra to a court order enjoining Vendor from disclosing any Proprietary Information to any Person or to enjoin any Person from receiving or using any such Proprietary Information. If such Proprietary Information or trade secrets are misappropriated or disclosed by Vendor, SMP Nutra shall also be entitled to the exclusive remedy of triple the profits of Vendor earned from, or triple SMP’s losses from (whichever is greater), the use or disclosure of SMP Nutra’s Proprietary Information, as a fair and reasonable projection of SMP Nutra’s future damages. Except as provided above, the rights and remedies under this Agreement are cumulative and shall not be exclusive, and the enforcement of one or more of such rights and remedies by a party shall in no way preclude such party from pursuing, at the same time or subsequently, any and all other rights and remedies available to it.

           12.3 Vendor hereby agrees to make available to SMP Nutra, at SMP Nutra’s request, the books, and records of Vendor for all sales relating to Customers of SMP Nutra.

13. Notices.

           Every notice or other communication required or contemplated by this Agreement must be in writing and sent by one of the following methods: (1) personal delivery, in which case delivery is deemed to occur the day of delivery; (2) certified or registered mail, postage prepaid, return receipt requested, in which case delivery is deemed to occur the day it is officially recorded by the U.S. Postal Service as delivered to the intended recipient; or (3) next-day delivery to a U.S. address by recognized overnight delivery service such as Federal Express, in which case delivery is deemed to occur one business day after being sent. In each case, a notice or other communication sent to a party must be directed to the address for that party set forth below, or to another address designated by that party by written notice:

14. Severability.

           If any provision of this Agreement or its application to any person or circumstances is determined by any court of competent jurisdiction to be unenforceable to any extent, that unenforceable provision will be deemed eliminated to the extent necessary to permit the remaining provisions to be enforced, and the remainder of this Agreement, or the application of the unenforceable provision to other persons or circumstances, will not be affected thereby. If any provision of this Agreement, or any part thereof, is held to be unenforceable because of the scope or duration of or the area covered by that provision, the court making that determination shall reduce the scope, duration of or area covered by that provision or otherwise amend the provision to the minimum extent necessary to make that provision enforceable to the fullest extent permitted by law.

15. Governing Law.

           This Agreement is governed by the laws of the State of New York, without giving effect to principles of conflict of laws. The parties hereby submit to the exclusive jurisdiction of the state and federal courts located in Suffolk County and the Eastern District of New York for the resolution of all disputes hereunder.

16. Amendments; Waivers.

           This Agreement may not be amended except by an instrument in writing signed by the parties. No waiver by any party of any breach under this Agreement will be deemed to extend to any prior or subsequent breach or affect in any way any rights arising by virtue of any prior or subsequent such occurrence. Waiver by either party of any breach by the other party will not operate as a waiver of any other breach, whether similar to or different from the breach waived. No delay on the part of the parties in the exercise of any of their respective rights or remedies will operate as a waiver of that right.

17. Counterparts.

This Agreement may be executed in counterparts, each of which shall be deemed to be an original, but all of which taken together shall constitute one and the same instrument.

The parties hereby execute this Agreement as of the date stated in the introductory clause.

Address:

Agreement Description: Supplier of

           SMP Nutra, Inc. (“SMP”) and Vendor may each be referred to herein individually as a “Party” and collectively as the “Parties”.

           SMP and Vendor wish to define the individual responsibilities of the Parties as to the quality aspects of manufacturing and release of the Products to ensure compliance with statutory and regulatory requirements applicable to Dietary Supplements.

           In order to do so, this Supplier Quality Agreement (“Quality Agreement”) takes the form, in part, of a detailed listing of activities associated with dietary supplement product manufacture, supply, packaging, testing and release of Product.

           Unless otherwise indicated, Responsibility for each activity is assigned to either SMP or Vendor or is assigned to both SMP and Vendor.

           IN CONSIDERATION of the Parties’ agreement to perform the activities provided in this Quality Agreement and for other valuable consideration the receipt and sufficiency of which is hereby acknowledged, and intending to be legally bound, SMP and Vendor agree as provided in this Quality Agreement as follows:

TABLE OF CONTENTS

Appendicies:

46-48 Appendix 1: Contacts and Responsibilities

1. Effective Date

           The Effective Date of this Quality Agreement shall be the date of last signature (“Effective Date”).

2. Scope

           This Quality Agreement outlines the responsibilities of SMP and Vendor with respect to the Quality Assurance and Quality Control of the Product supplied for SMP by Vendor.

           The “AREAS OF RESPONSIBILITY” for each party are identified in Appendix 1: Contacts and Responsibilities and each party agrees to perform its respective areas of responsibility in a skillful and professional manner and on a timely basis .

3. Supply Agreement/Inconsistent or Conflicting Terms

            The rights, obligations and responsibilities of the Parties as set forth in any Vendor Agreement that may have been entered into by and between the Parties (including, without limitation, all of the representations and warranties of the Parties and all of the rights and obligations of the Parties related to Indemnification, Product Recall, and Product Warranties) and the general provisions of such Vendor Agreement shall govern, in all respects, the performance of the Parties under this Agreement. To the extent that any of the terms of this Agreement are inconsistent or in conflict with any terms of any such Vendor Agreement, or in the event there is any ambiguity between such Agreements, the Vendor Agreement shall have exclusive control and prevail in all respects, and all such inconsistent or conflicting terms in this Agreement along with any terms in this Agreement which result in such ambiguity, shall be of no force or effect.

4. Amendments to Quality Agreement

            No amendment to the terms of this Agreement shall be binding on the Parties hereto unless made in writing and signed by an authorized representative of each of the Parties.

           The Parties agree to amend the terms of this Quality Agreement in order to ensure that the Product meets changes to applicable statutory and regulatory requirements as may be promulgated from time to time.

           If an amendment to this Quality Agreement is proposed, the proposing Party will circulate the proposed amendment in writing to the appropriate contact person at SMP and Vendor for review and internal approval.

           The contact personnel responsible for Business and Quality Management decisions at SMP and Vendor are listed in Appendix 1 – Contacts and Responsibilities. The parties agree to promptly notify one another of personnel changes, which may be added or deleted to the Contacts and Responsibilities List upon written notice to the other party.

5. Term of Quality Agreement

           This Quality Agreement shall commence on the Effective Date and shall remain in effect for as long as SMP dictates.

6. Use of Third Parties

           Vendor shall not use in any capacity the services of any third party to package, label, inspect, release, handle and/or process the Product for SMP, unless SMP provides prior written consent to Vendor for such. Before SMP grants any such written consent, SMP may require that Vendor enter into a written agreement with the third party (“Third Party Agreement”) to the satisfaction of SMP.

           This Third-Party Agreement shall define the respective quality responsibilities of Vendor and the Third-Party Agreement shall provide for confidentiality and non-disclosure of all SMP confidential information requiring at least the same degree of protection for SMP’s confidential information consistent with the obligations of confidentiality and non-disclosure that exists between the Vendor and SMP. The Third-Party Agreement must be approved in writing by SMP prior to its execution by Vendor and the third party.

           Vendor shall retain all obligations to SMP under this Quality Agreement, whether or not a Third Party packages, labels, inspects, releases, handles and/or processes the Product for Vendor.

7. Survival Clause

           The obligations of confidentiality contained in the Vendor Agreement, shall survive termination of this Quality Agreement (as provided in the Vendor Agreement).

            All regulatory obligations contained herein that are required of either Party or both Parties by an applicable regulatory authority shall survive termination of this Quality Agreement.

8. Assignment

            Vendor shall not assign any or all its rights or delegate any of its obligations under this Quality Agreement without SMP’s prior written consent. SMP’s consent shall not be required in connection with a merger, consolidation, or sale of all or substantially all of Vendor’s assets or the subject matter of this Quality Agreement to another party (“Assignment Transaction”). In the event of an Assignment Transaction, Vendor shall provide written notice to SMP to the appropriate contact person indicated in Appendix 1 – Contacts and Responsibilities.

            SMP shall have the right to assign any or all its rights or to delegate its obligations under this Quality Agreement without the consent of Vendor. In the event of an Assignment, the assigning Party shall continue to be bound by all pre- existing obligations under this Quality Agreement, including all obligations of confidentiality and non-disclosure.

9. Resolution of Quality Disputes

            Quality related disputes between SMP and Vendor that are not resolved in the normal course of business shall be brought to the attention of the appropriate contact person for notices at SMP and Vendor, in writing, as listed in Appendix 1 – Contacts and Responsibilities. If both Parties agree that a resolution of the dispute is reasonably possible, then both SMP and Vendor shall agree to work jointly to develop a strategy for such resolution. SMP and Vendor further agree to record such resolution in writing.

            In the event that the Parties are not able to work out a resolution to a Quality-related dispute, then both SMP and Vendor shall agree to work jointly to identify an arbitrator or a consultant to facilitate resolution of the dispute. The arbitrator or consultant shall be Independent and must be agreed to by both Parties and shall not have a conflict of interest to either Party.

10. Audits & Facility Inspections

            SMP reserves the right upon not less than sixty (60) days (calendar) notice and no more than once per calendar year, and for reasonable purposes at its expense, to audit Vendor facilities and Quality Management System (QMS). These audits may be performed by employees or other agents of SMPs, including Independent Outside Auditors or Consultants, on-site during normal business hours and may include Records, Facilities, Equipment and Warehouses used in the control of SMP Product(s).

            Notwithstanding the foregoing, the once per calendar year limitation shall not apply to any period of twelve months in which there is any Product Recall, Withdrawal or Critical Deviation that results in corrective action(s) to be implemented by Vendor.

            In the event the Vendor facility is inspected by any regulatory authority, Vendor shall promptly notify SMP within 24 hours, to the extent that such inspection impairs Vendor’s ability to package or store the Product(s), of (i) any such inspection with reasonable advanced notice, (ii) any alleged written violations or deficiencies related to the packaging facility, and (iii) the corrective action to be taken, and shall promptly contest such alleged violations or deficiencies in good faith or take the required corrective action, each at Vendor’s sole expense. In the event that an inspection is specific only to SMP(s) Products, Vendor shall permit a representative of SMP to be present during any such inspection.

            Vendor shall keep SMP fully advised of, and provide SMP with the opportunity to comment on, any filings, notices, or other correspondence, and to participate in any meetings or discussions with any regulatory authority that could reasonably be expected to impair Vendor’s ability to package or store the Product(s).

11. Change Control

            Vendor will use a documented system of procedures for change control, planned or unplanned, to packaging materials, labeling, suppliers, equipment, sampling, processing and release requirements. Any major changes that directly impact product(s) made for SMPs, whether planned or unplanned, shall be reviewed and approved by SMP prior to implementation. Changes proposed by Vendor will be evaluated within ten (10) business days of notification.

            Changes (not intended as a complete list) that affect the manufacturing, labeling, packaging, quality control are considered major changes and will require SMP review and approval prior to implementation. Changes that are editorial in nature or format-related changes, which do not change the scientific or technical content or original intent are considered minor changes and warrant a passive written notification to SMP that a change has occurred.

12. Product Complaints & Serious Adverse Events

            SMP is responsible for receiving, recording, follow-up, and responding to customer/consumer complaints including Adverse Events and Serious Adverse Events. SMP, in certain cases, may request that Vendor perform testing or additional follow-up to obtain information to aid in a complaint investigation. Vendor is responsible for the technical investigation of Product complaints, Adverse Events and Serious Adverse Events upon SMP’s request. When appropriate, SMP will administer the return of the actual complaint sample to Vendor.

            Vendor will complete the Quality Investigation within thirty (30) calendar days of receipt, except that high priority complaints shall be investigated as practical within fourteen (14) calendar days. Vendor will issue a copy of the completed investigation report to SMP within five (5) business days of completion of complaint investigation. Vendor shall communicate any delays pertaining to the investigation of a product quality complaint and provide written notice as to the cause of the delay.

            If Vendor receives direct customer or consumer inquiries, complaints, Adverse Events or Serious Adverse Event Reports from a Party other than SMP pertaining to their Product(s), Vendor will process the communication as per its internal procedures and shall provide such information promptly to SMP.

            Both Parties shall notify each other immediately, but in any case, within five (5) calendar days of any significant complaint or any potentially serious Adverse Event received.

            SMP is responsible for reporting Serious Adverse Events to the FDA if and when required under the Dietary Supplement Non-Prescription Drug Consumer Protection Act.

§	Quality Requirement
1.0	General Compliance Requirements
1.01	Follow applicable regulations for Foods and Dietary Supplements as codified in 21 CFR Parts 1-199 as applicable.
1.02	Always maintain GMP Inspection Readiness. Notify Parties of Regulatory GMP Inspection that specifically focuses on compliance related to the Product(s) or an inspection outcome that may impact the compliance status of the facilities and their ability to produce product.
1.03	Notify SMP within twenty-four (24) hours of any pending or ongoing regulatory authority inspection or communication related to the Product, or the facilities used to produce, test, or warehouse the Product. In the event that the inspection is specific only to SMP Product, Vendor shall permit a representative of SMP to be present during any such inspection.
1.04	Maintain appropriate registrations and/or licenses applicable to the manufacture of the Product required by Federal, State and Local laws.
1.05	Operate in compliance with applicable environmental, occupational health and safety regulations as required by Federal, State and Local laws.
1.06	Notify SMP of any notice of violation or request for information from FDA, FTC, CPSC or other government agency (Federal, State or Local) that might pertain to the Product(s) or the facilities used in the manufacture and/or testing of the Product(s).
1.07	Notify SMP of requests for information, notices of violations or other communication from a government agency relating to environmental, occupational health and safety compliance that impact personnel, facilities and/or equipment.

1.08	Maintain internal Good Manufacturing Practices Audit Program.
1.09	File Structure Function Claims (Section 403(r)(6)) to FDA to support Post Market Notification Requirements to FDA.
1.10	Notify and provide copies to SMP electronically within twenty-four (24) hours of correspondences to and received from regulatory authorities (Federal, State and Local) related to SMP Product.
1.11	Provide a copy of FDA Form 483, EIR, Warning Letter, Untitled Letters to SMP within three (3) days of receipt. Documents may be redacted as required to exclude proprietary information of other customers. Allow SMP to review and comment on the response, relevant to Product(s) supplied to SMP, prior to submission of the response to the regulatory authority.
1.12	Notify Vendor of any regulatory compliance observation received by SMP Health Products that pertains to operations performed by Vendor.
2.0	Sub-Contracting
2.01	Notification to SMP if Sub-Contracting is required prior to execution of sub-contracting operations. SMP shall reserve the right to reject a proposed supplier based on compliance concerns.
2.02	Prior to engaging the Sub-Contractor with any information including documentation, Vendor shall execute an appropriate Non-Disclosure or Confidentiality Agreement with the Sub- Contractor.
2.03	Maintain Sub-Contractor approval status following pre-established procedures which include requirements for qualification.
2.04	If Vendor engages a Sub-Contractor, SMP shall have the right to audit the Sub-Contractor under the same terms and conditions that Vendor grants access to SMP for Quality Systems Audits.
3.0	Change Control (see previous Section 11 – Change Control)
3.01	Have approved written procedures for control of changes impacting the Product including but not limited to process materials, packaging materials, labeling, and computer hardware/software. Include in written procedures the process and criteria for customer notification and approval, follow-up and closure of changes.
4.0	Personnel
4.01	Provide sufficient training to meet GMP obligations and execution to the requirements of this Quality Agreement. Assure training is regularly conducted, assessed and documented by qualified individuals. Written procedures documenting the Training Program shall be established and approved by Quality personnel.
4.02	Notify SMP of key organizational and/or key personnel changes, including changes that impact Appendix 1 – Contacts and Responsibilities.

4.03	Provide adequate number of personnel qualified by appropriate training, education and experience to perform and supervise the packaging and disposition of the Product(s).
4.04	Have written Job Descriptions for all personnel responsible for performing Good Manufacturing Practice-related activities.
4.05	Document Personnel Responsibilities in written procedures and train individuals to ensure they understand their responsibilities.
5.0	Physical Plant and Grounds
5.01	Package, ship, and store the Product(s) and components in facilities meeting applicable cGMP requirements. Facilities shall be designed, constructed and maintained in a manner that a) permits the operation therein to be performed under clean, sanitary and orderly conditions; b) permits the effective cleaning of all surfaces; and c) prevents the contamination of the Product and minimizes the potential for the ingress of extraneous material into the Product(s); (d) provides physical and spatial separation to minimize the potential for cross-contamination and mix-ups.
5.02	HVAC and Dust Collection Systems will be designed and maintained to minimize the risk of contamination.
5.03	Vendor shall dispose of sewage, refuse, and other waste in a safe and timely manner following applicable environmental health and safety regulations.
5.04	Maintain a set of current drawings for critical utilities including water, electrical, compressed gases, HVAC, and Dust Collection. Legacy Systems that pre-existed this Agreement may be exempted if the equipment is standard to the industry and well-maintained in a calibrated state as necessary.
5.05	Maintain user manuals for all equipment that supports facility utilities such as electrical, HVAC, dust collection, compressed air and water.
5.06	Maintain and document an adequate pest control program.
5.07	Provide requested information to SMP within ten (10) days of notification or as required to meet regulatory obligations.
5.08	Maintain a comprehensive Sanitation and Zoning Program to minimize the potential for cross- contamination. Program shall be based on Risk Management Principles.
5.09	Maintain a list of Cleaning and Sanitizing Chemicals and ensure that these are suitable for Food Manufacturing applications.
5.10	Maintain documentation to ensure that the Water Supply meets appropriate EPA Potability requirements as defined in 40 CFR.
5.11	Maintain adequate hand washing facilities to minimize the potential for cross- contamination.
6.0	Equipment and Utensils

6.01	Ensure that equipment is adequately designed, qualified and suitable for its intended use in Dietary Supplement Packaging.
6.02	Use appropriate Food Grade cleaning and sanitizing agents.
6.03	Maintain current User Manuals for all major equipment. Legacy equipment that pre-existed this agreement may be exempted if the equipment is standard for the industry and maintained in a good state of repair.
6.04	Establish an Equipment Calibration Program that documents frequency, calibration limits, calibration standards and methods.
6.05	Establish a Preventative Maintenance Program to ensure optimum performance of equipment and to prevent equipment malfunctions from compromising the Identity, Strength, Purity and Composition of Product(s).
6.07	Maintain calibration and preventive maintenance procedures and schedules for equipment/instruments used in the packaging, testing and verification/qualification of the Product(s). Include calibration tagging where appropriate.
6.08	Document, review and approve (including calibration performed by Sub-Contractor) packaging equipment.
7.0	Production and Process Control Systems
7.01	Establish a Process Control System that covers all stages of Packaging, Labeling and Holding of a Dietary Supplement.
7.02	Establish Specifications which document the Identity, Strength, Purity, Composition and Limits on Contaminants for all components (includes labeling, packaging materials, as applicable)
7.03	Establish In-Process Specifications to ensure that the Identity, Strength, Purity, Composition and Limits on Contaminants are not compromised during Packaging or Holding operations.
7.04	Establish Finished Product Specifications which document the Identity, Strength, Purity, Composition and Limits on Contaminants for the finished dosage form (Name of Bulk).
7.05	Collect representative samples of in-process materials and finished dosage forms for evaluation against all pre-established specification requirements at pre-determined intervals.
8.0	Quality Control
8.01	The Parties shall ensure that the authority and responsibilities of Quality personnel are documented in writing.
8.02	The Parties shall ensure that personnel making Material Use and Disposition Decisions have no conflict of interest and are independent of Operations, Marketing, Sales and any other functional area that may have a conflict of interest.

8.03	Vendor Quality personnel shall review and approve all Specifications (testing parameters, acceptance criteria), Written Procedures, Test Methods, Planned and Unplanned Deviations as required under 21 CFR Part 111.
8.04	Vendor Quality personnel shall review and approve all documentation that justifies the basis for the qualification of any Supplier, including but not limited to, Packaging Materials, and Labeling (If Applicable).
8.05	Vendor Quality personnel shall ensure that all executed documentation representing any specific batch of Product is reviewed, rejected and approved based on the results of testing and/or examinations against Identity, Strength, Purity, Composition and Limits on Contaminants specification limits.
8.06	Vendor Quality personnel shall ensure that representative samples are collected for all in-process materials and finished packaged product to ensure that data generated in support of batch release and rejection is representative of the batch.
8.07	Vendor Quality personnel shall ensure that retain or reserve samples are collected and held under appropriate conditions of storage and time periods.
8.08	Vendor Quality personnel shall be responsible for reviewing and approving records of Calibrations on all equipment unless equipment is specifically exempt from calibration requirements.
9.0	Components, Packaging and Labeling
9.01	Vendor shall establish a Supplier Quality Management Program that addresses Component and Supplier Qualification. Minimum elements shall include Certificate of Analysis Verification provisions for all Suppliers. SMP may audit suppliers in lieu of Vendor conducting an audit. The program shall also include periodic requalification of Suppliers. The frequency for periodic requalification of components and suppliers may be based on Risk Management Principles (variable frequency based on component & supplier risk factors).
9.02	Vendor shall inspect incoming materials in accordance with its Supplier Qualification Program and procedures.
9.03	Vendor shall quarantine components either physically or electronically until a Material Use and Disposition Decision has been made by Quality personnel. Materials that are rejected shall be promptly returned to the Supplier and segregated to prevent accidental use until return is practical.
9.04	Vendor shall ensure that all components are fully traceable based on unique identifiers that include Part Numbers and Batch Numbers.
10.0	Analytical Laboratory Operations
10.01	Vendor shall have appropriate procedures for conducting Out of Specification investigations for data generated by in-house laboratories or external third-party laboratories.
10.02	Vendor shall have appropriate procedures for the identification, investigation, reporting, tracking, trending, and closure of deviations.

10.03	Vendor shall document and notify SMP of any deviation (see definition in 10.02) affecting the quality of the Product(s) and/or any failure to document the process in accordance with written procedures and cGMPs. Notify SMP within three (3) days of any deviation on a component, in-process material or finished dosage form.
10.04	Parties will notify each other within twenty-four (24) hours of first knowledge of all test results that indicate a product does not meet pre-established specifications. This includes both Quality Control results and Stability test results.
10.05	Vendor shall provide investigation documentation to SMP upon request.
10.06	SMP shall assist Vendor with investigations when Vendor requests, or when SMP deems appropriate.
10.07	Vendor shall complete investigations within thirty (30) days of incident discovery. Vendor shall not extend any investigation beyond the original thirty (30) day period without the written consent of SMP. Vendor shall provide reason for any delay that results in an investigation beyond thirty (30) days. The parties agree that high priority investigations shall be expedited and completed as soon as practical.
10.08	Vendor shall complete corrective action commitments resulting from investigation closure within the time period committed. Communicate any reason for delays or failure to meet commitments and the reason for the delay or failure.
10.09	Vendor shall ensure that methods for testing and examination are appropriate for their intended use.
11.0	Packaging and Labeling Operations
11.01	Vendor shall ensure that Packaging Operations for finished products be so designed as to protect the integrity of the Product from cross-contamination and exposure to elevated humidity and temperatures. When appropriate, environmental monitoring shall be conducted and documented.
11.02	Vendor shall ensure that Bulk Labeling Operations are designed to minimize the potential for mix-ups.
11.03	Vendor shall ensure that Packaging Operations prior to production of product on behalf of have been cleaned and sanitized as necessary to prevent cross- contamination. Cleaning and sanitizing shall be independently verified by a second person and documented in the Packaging Batch Record or in an Equipment Cleaning and Use Log. The supplier shall develop specific controls to minimize the potential for Foreign Dosage Form ingress in packaging operations as necessary.
11.04	Vendor shall ensure that Packaging Operations prior to production of product on behalf of SMP have been cleared of all materials from the previous product run. Line clearance shall be independently verified by a second person and documented in the Packaging Batch Record or in an Equipment Cleaning and Use Log.

11.05	Vendor shall have procedures in place to reconcile all critical packaging components against theoretical yields and pre-established specification limits. This includes primary container labeling and bulk product but may exclude shipper labels.
12.0	Holding and Distribution
12.01	Vendor shall ensure that all components, in-process materials and finished dosage forms are held under appropriate conditions of temperature and humidity to protect the Identity, Strength, Purity and Composition of the Product(s).
12.02	Vendor shall document environmental storage conditions by monitoring and recording temperature and humidity conditions within key areas of the facility. Specifications for environmental storage shall be established and be based on the threshold values for which the Finished Dosage Form will begin to show detrimental effects from temperature and humidity.
12.03	Vendor shall ensure that labeling for components, in-process materials and finished dosage forms includes temperature and humidity limit requirements for Holding and Distribution, where appropriate.
12.04	Vendor shall ensure that components, in-process materials and finished dosage form materials are held in such a manner as to ensure that their status is conspicuous. The system for managing materials may be electronic or through the use of Quarantine stickers or by other physical means. Rejected Product shall be stored in a separate location and labeled as Rejected. Rejected Product shall be removed from the facility and destroyed as soon as practical.
13.0	Returned Dietary Supplements
13.01	The Parties agree to evaluate Returned Dietary Supplements against all pre-established specification requirements for the purpose of making a Material Use and Disposition Decision. Returned Dietary Supplements not meeting pre-established specification requirements shall be destroyed. If material is returned for overstock reasons, the assessment can be made based on the physical condition of the product applying reduced sampling procedures.
13.02	If a dietary supplement is returned for Quality reasons and the Quality defect is confirmed, the Parties agree to evaluate the impact of the defect on other batches of the same or similar Products produced.
14.0	Product Complaints
14.01	Vendor shall have written procedures in place to investigate, review and approve all investigations pertaining to Quality Complaints. Vendor shall issue Complaint Investigation Reports within thirty (30) calendar days from the date of receipt.
14.02	Vendor shall review and approve or request additional information pertaining to SMP Complaint investigations within five (5) calendar days of the receipt of the report.
14.03	Vendor and SMP shall notify each other within five (5) calendar days of a Product Complaint that may be classified as a Serious Adverse Event reportable under the Dietary Supplement Non-Prescription Drug Consumer Protection Act. Vendor bears the responsibility for filing Serious Adverse Event Reports for all dietary supplement products supplied by Vendor to SMP.

14.04	The Parties agree that Complaints that may represent significant Quality Events (e.g. Foreign Tablets, Extraneous Material, Adverse Events and Serious Adverse Events) will be subjected to an expedited investigation. The timing for an expedited investigation shall be agreed to by both parties.
14.05	SMP and Vendor Quality/Regulatory personnel will review and approve all pertinent Complaint Investigations.
14.06	Vendor shall assist in investigations of Product related complaints, as requested by SMP.
14.07	The Parties shall evaluate Complaints through their own Standard Operating Procedures and report on Complaint Trends that may warrant changes to the Packaging, Labeling and so on.
15.0	Records and Recordkeeping
15.01	Vendor shall retain, archive, manage and obsolete all GMP records pertaining to Services performed for SMP in accordance with GMP requirements. Records shall be kept for a minimum of one year past the expiry date of the Product(s) or in accordance with Supplier Record Retention Policy, whichever is longer.
15.02	Vendor shall take reasonable precautions to ensure that records are protected from a catastrophe such as fire or flood.
15.03	Vendor shall have a documented Records Retention Policy.
16.0	Rework
16.01	Vendor shall contact SMP prior to performing any rework on packaged product that requires that the product be reprocessed. Reprocessing for Packaging is defined as dumping finished goods back to bulk and repackaging. Vendor May 100% inspect product for AQL defects at their discretion to remove or minimize defects such as cosmetic defects, crooked labels, defective seals, etc. without prior notice to SMP; however, a statement documenting the results of the inspection must be included on the Certificate of Analysis.
16.02	Vendor shall submit formal rework protocol if a request is made to SMP to rework Product through reprocessing. SMP shall approve or reject any proposed request for rework submitted by Vendor. If SMP rejects a vendor rework proposal, then SMP must provide justification for doing so.
17.0	Stability
17.01	Vendor will maintain a documented ongoing Stability Program to monitor the stability characteristics of the Product using approved analytical methods applicable to measuring the Identity, Strength, Purity and Composition of the Product.
17.02	Vendor agrees to apply measurement uncertainty to the dietary ingredient assays for the purpose of establishing an expiration date. Measurement uncertainty estimates shall be developed in accordance with standard industry practice using routine quality control data and shall be consistent with FDA requirements codified in 21 CFR 101.9(g).
17.03	Both Parties agree to perform final package stability studies.
18.0	Recalls

18.01	Vendor shall notify SMP in writing within twenty-four (24) hours of any SMP Product defects that could result in a Product Recall or abnormal restriction on the supply of Product.
18.02	SMP and Vendor shall have approved procedures for Recall that address the decision- making process, correspondence with regulatory agencies, management of recalls, and reconciliation of returned Product.
18.03	The Parties agree to investigate any Quality defect that results in Recall and to take corrective action to ensure that future production is not adulterated or misbranded.
18.04	Vendor shall review correspondence for submission to regulatory agency, as requested by SMP.
18.05	Vendor shall assist SMP to manage recall and reconciliation of returned Product as requested by SMP.

APPENDIX 1: CONTACTS AND RESPONSIBILITIES

	SMP
	QUALITY CONTROL	QUALITY CONTROL
NAME	Barbaro Guerrero
TITLE	Quality Control Manager
PHONE/FAX	(833) 810-9896
ADDRESS (mail/delivery)	1 Rodeo Drive Edgewood, NY 11717
ELECTRONIC	quality@smpnutra.com
	QUALITY ASSURANCE	QUALITY ASSURANCE
NAME	Amber Palazzo
TITLE	Compliance

PHONE/FAX	(833) 810-9896
ADDRESS (mail/delivery)	1 Rodeo Drive Edgewood, NY 11717
ELECTRONIC	compliance@smpnutra.com
	PURCHASING MANAGER	PROCUREMENT MANAGER
NAME	Larry Simon
TITLE	Chief Operating Officer
PHONE/FAX	(833) 810-9896
ADDRESS (mail/delivery)	1 Rodeo Drive Edgewood, NY 11717
ELECTRONIC	larry@smpnutra.com
CONTACT PERSON FOR NOTICES (Including Notices of Amendment, Assignment, Termination, Resolution of Quality Issues)
NAME	Komal Saini
TITLE	Contract Administrator
PHONE/FAX	(833) 810-9896
ADDRESS (mail/delivery)	1 Rodeo Drive Edgewood, NY 11717
ELECTRONIC	legal@smpnutra.com