Product Supply And Distribution Agreement PdfBy Repetaskba In and pdf 30.03.2021 at 21:18 9 min read
File Name: product supply and distribution agreement .zip
- Distribution Agreement
- Distribution Agreement
- 49+ SAMPLE Distribution Agreement Templates in PDF | MS Word
The following bold terms have the meanings set forth in this Agreement:. If the manufacture of any component of the finished dosage is performed for DRL by a Third Party and not accounted for in the Transfer Price, then such amounts paid to such Third Party in connection with the manufacturing of the component thereof shall be included in DRL Finished Dosage Manufacturing Cost when applicable. Mikah is responsible for identifying and transferring the Product to a different facility, if needed and only to the extent the different facility consents to inspections and audits by DRL under Section 5. In no case shall the Net Profit for any Calendar Quarter be negative; provided, however, in the event of a loss in any Calendar Quarter, the amount of that loss shall be carried forward to subsequent Calendar Quarters until the amount of such loss has been fully absorbed by future Net Profits.
The following bold terms have the meanings set forth in this Agreement:. If the manufacture of any component of the finished dosage is performed for DRL by a Third Party and not accounted for in the Transfer Price, then such amounts paid to such Third Party in connection with the manufacturing of the component thereof shall be included in DRL Finished Dosage Manufacturing Cost when applicable.
Mikah is responsible for identifying and transferring the Product to a different facility, if needed and only to the extent the different facility consents to inspections and audits by DRL under Section 5. In no case shall the Net Profit for any Calendar Quarter be negative; provided, however, in the event of a loss in any Calendar Quarter, the amount of that loss shall be carried forward to subsequent Calendar Quarters until the amount of such loss has been fully absorbed by future Net Profits.
DRL shall not deduct any cost for sales and marketing. Net Sales with respect to sales of the Product that are not made on an arm's length basis or that are made for consideration other than cash shall be calculated based on the average per-unit Net Sales of the Product without regard to such non-arm's length or non-cash sales.
For the avoidance of doubt, the use of Supplier in this Agreement shall be interpreted to mean that Mikah shall or shall not perform and Mikah shall ensure that Contract Manufacturer shall or shall not perform the duties and obligations referenced herein.
Each Product shall be manufactured at the Facility in accordance with the Specifications, Applicable Laws, and the terms and conditions of this Agreement. Supplier shall not implement any change in the Specifications that may be noticeable by the consumer until the Parties have agreed in writing to such change, the implementation date for such change, and any increase or decrease in costs, expenses or fees associated with such change.
Supplier shall respond promptly to any request made by DRL for a change in the Specifications, and both Parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. No other trademarks, logos or trade names shall be displayed on the Product labels, except as may be required by law or regulation.
DRL shall provide Supplier with proposed label and labeling specifications for the Product as soon as practicable after the execution of this Agreement. DRL shall provide Supplier with reasonable notice of all labeling or packaging changes or requests for additional labels or packaging. DRL shall provide Mikah and the Contract Manufacturer with non-binding rolling twelve 12 month forecasts of its Product requirements by delivery date.
DRL shall order based on batch size as provided in Exhibit A. For every delivery, per Product, a firm binding order must be made at least three 3 months in advance of delivery date or such lesser period of time that the Parties may agree to, in writing.
Supplier shall confirm the order and projected date of shipment within seven 7 calendar days after having received a Purchase Order. Supplier shall not be obligated to fulfill any order received less than three 3 months prior to a requested shipment date for any Product, however Supplier shall use commercially reasonable efforts to accommodate any requested shipment date.
To the extent such Purchase Order contains terms or conditions that are in conflict with the terms and conditions of this Agreement, the conflicting terms or conditions of the Purchase Order will have no effect, unless Supplier agrees, in writing, to such terms or conditions or that such terms and conditions will supersede the terms of this Agreement.
All Product delivered hereunder shall be suitably packed for shipment by Supplier in accordance with good commercial practice, and instructions provided to Supplier by DRL, with respect to protection of such Product during transportation, marked for shipment to DRL. Such shipment shall also include a certificate of analysis and a certificate of compliance in accordance with the terms of the Quality Agreement.
Supplier shall choose a commercially reasonable carrier, acceptable to DRL for each shipment of Product, unless DRL or its Affiliates have specified a particular carrier in its Purchase Order. Failure to Supply Charges will be charged back to Mikah. All delivered Product shall be in full cases, and shall be on heat treated pallets. For the avoidance of doubt, DRL will not accept Product delivered in partial cases or on chemically treated pallets.
Mikah shall be responsible for any and all facility licenses or finished dosage form manufacturing site fees established under GDUFA and shall comply with GDUFA requirements including self-identification. Mikah, shall be ensure that the Regulatory Agent manages all pharmacovigilance activities related to Product, including but not limited to: Individual Case Safety Reporting, Periodic Aggregate Event Reporting and Serious Signal detection as required by 21 C.
Mikah shall ensure that a pharmacovigilance infrastructure is maintained as required to fulfill its responsibilities under this Agreement and the Pharmacovigilance Agreement. All out of pocket cost shall be shared equally by the Parties. If there is inconsistency between the terms of such quality agreement and this Agreement, the terms of this Agreement shall control. The Transfer Price as of the Effective Date, based on the expected commercial batch size, is indicated in Attachment 2.
The Transfer Price is the price per Unit paid by DRL to Mikah for the purchase of a Product, which price shall be the total of all actual direct and indirect manufacturing costs including the cost of:. For the avoidance of doubt, the Transfer Price includes all costs related to the procurement, manufacturing, testing, release, stability, and regulatory activities for the Product. The "commercial conversion costs" shall not include idle capacity variances.
All amounts payable with respect to the delivery of Product as opposed to the profit share payment described in Section 3. All invoices will be sent to the address specified in the applicable purchase order, and each invoice will state the aggregate and unit price for Product in a given shipment.
The Parties agree to pursue a continuous improvement strategy to seek ways to improve their overall business practices and manufacturing performance and reduce both of their costs.
Any adjustments to be made in respect of payments previously made to Mikah due to rebates, returns and the like, shall be factored into the calculation of subsequent payments. Mikah shall maintain records and documents documenting the Transfer Price of each of Product and DRL shall maintain all records documenting Net Sales to the sale of Product for a time period equal to the period required by Applicable Laws.
The audited Party shall cooperate in any audit by allowing the auditor access to all records necessary for the auditor to conduct such audit. Mikah and DRL agree to work together with the auditor in good faith to resolve any disputes arising out of any audit in a timely, professional and non-adversarial manner. All such audits shall be performed during regular business hours and under reasonable confidentiality provisions which shall include that such auditor shall be bound by the confidentiality provisions contained in this Agreement.
All taxes and duties assessed on the Product, prior to or upon sale to DRL are the responsibility of Mikah. If any payment under this Agreement is subject to a local withholding tax, the Party that is paying the relevant sum shall withhold the appropriate tax amount and shall timely provide the other Party with a certificate evidencing its actual payment of the withholding tax to the local tax authorities.
The Parties shall use reasonable commercial efforts to collectively address any withholding tax requirements prior to the date such payments are to be made. Mikah shall, at its own cost and expense, supply DRL with any missing quantities of Product as soon as reasonably possible after receipt of such notice. Subject to the foregoing, DRL shall have the right to reject any batch of Defective Product prior to the expiry of such batch of Product.
A Product that is not rejected within the applicable period of time shall be deemed accepted by DRL. If Mikah agrees that a batch constitutes Defective Product, Mikah shall, at its option, replace the Defective Product or repay the full amount of any payments, including shipping costs, made by DRL for such Product. If such results indicate that the Product was Defective Product, Mikah shall replace the Defective Product or repay the full amount of any payments, including shipping costs, made by DRL for such Product.
Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the non-prevailing Party. Supplier shall maintain true and accurate books, records, test and laboratory data, reports and all other information relating to Manufacturing under this Agreement, including all information required to be maintained by all Applicable Laws. Such information shall be maintained in forms, notebooks and records for a period of at least two 2 years from the relevant finished Product expiration date or longer if required under Applicable Laws.
DRL shall be solely responsible for all permits and licenses required by any Regulatory Authority with respect to the distribution of the Product, including any product licenses, applications and amendments in connection therewith. Mikah, as the Party owning Application, shall have responsibility for monitoring and ensuring the compliance with all statutes, regulations, guidelines and other requirements of the Regulatory Authority pertaining to the Product and the applicable Regulatory Approval including permits and licenses with respect to Application, and ensuring that the Facility and its equipment, and the Manufacture of the Product are in compliance with Application and the Specifications.
Each Party intends and commits to cooperate to satisfy all Applicable Laws, regulations and practices within the scope of its respective responsibilities under this Agreement. Mikah shall notify DRL immediately of any correspondence, any inspections, and the result of any inspection s with the FDA or any Regulatory Authority directly related to the Product.
Mikah shall send a draft to DRL of all correspondence Mikah intends to send to any Regulatory Authority directly related to the Product. For all correspondence with a Regulatory Authority directly related to the Product that is not in response to a regulatory deficiency or problem, DRL shall have seven 7 business days to approve the draft correspondence, and if DRL is silent after seven 7 business days, it is understood DRL gives its constructive consent to the correspondence.
For all correspondence with a Regulatory Authority directly related to the Product that is in response to a regulatory deficiency or problem, DRL shall have the absolute right to approve the draft correspondence before such correspondence is sent to the Regulatory Authorities. In such a case, DRL will make every effort to act expediently in approving the draft correspondence. With respect to Product, each Party shall comply with the national system for tracing pharmaceutical products through the supply chain, as set forth in the Drug Quality and Security Act H.
Each Party shall promptly inform the other, in writing, of any inspection, application for inspection, and other regulatory action, by any regulatory agency relating to the Product or the Manufacture of Product or, in the case of the Supplier, the Facility at which Supplier Manufactures, packages, tests or stores the Product.
In the case of a Recall or Product Action, each Party shall make a complete and accurate record of all out-of-pocket costs incurred by it in connection with the Recall or Product Action, a copy of which shall be delivered to the other Party upon request as soon after the completion of such Recall or Product Action as may be practicable.
DRL and Mikah shall each have the right, in their sole discretion and at their sole cost, to use a Third Party to assist with its obligations relating to a Recall or Product Action. To the extent and in the proportion the cause or reason of any such recall, withdrawal, field correction or seizure of Product is directly attributable to activities performed by Supplier in the manufacture of the Product, Mikah shall be responsible for the Recall Costs and replacement of the Product at its own cost.
To the extent and in the proportion the cause or reason of any such recall, withdrawal, field correction or seizure of Product is directly attributable to activities performed by DRL with respect to distribution of the Product, DRL shall be responsible for the Recall Costs and replacement of the Product at its own cost. To the extent the cause or reason of any such recall, withdrawal, field correction or seizure of Product cannot be determined, the Parties shall be responsible for the recall expenses and replacement of the Product in the ratio of their profit sharing percentage.
DRL shall have access to the results of any tests performed by Supplier relating to Product and the processes or materials used in their Manufacture. Mikah shall use its best efforts to ensure that DRL has similar access to the facilities, data and records of Contract Manufacturer and its agents. Such inspections do not relieve Supplier of any of its obligations under this Agreement or create new obligations on the part of DRL.
This right of inspection can be exercised at least once a year, provided written notice is given to Mikah at least two weeks prior to the inspection, or at any time for cause.
Mikah shall permit such inspection during normal business hours at reasonable and mutually acceptable times, accompanied at all times by a Supplier representative. Mikah hereby represents, warrants and covenants to DRL that:. Mikah agrees to immediately notify DRL should any Regulatory Authority threaten any action that could possibly result in a breach of this Section;.
DRL hereby represents, warrants and covenants to Mikah that:. Each Party hereby represents, warrants and covenants to the other Party that:. Existence and Power. Such Party: a is duly organized, validly existing and in good standing under the laws of the state or province in which it is organized, b has the power and authority and the full legal right, power and authority to own and operate its property and assets, and to carry on its business as it is now being conducted, and c is in compliance with all requirements of Applicable Laws.
Such Party: a has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder and b has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;.
This Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms;. All necessary consents, approvals and authorizations of all Regulatory Authorities and other persons required to be obtained by such Party in connection with the Agreement have been obtained; and. Mikah hereby grants to DRL an exclusive license under the Mikah IP to use, import, export, sell, offer for sale, have sold and otherwise Commercialize the Product in the Territory during the Term.
Each Party will support any such litigation with supportive materials and direct participation in any deposition as requested or required by the other Party. The Indemnifying Party shall have the sole and exclusive right to select counsel to defend any such claim and final decision-making authority regarding all aspects of the defense of such claim.
Notwithstanding the foregoing, 1 the Indemnified Party shall have the right to retain its own separate counsel in connection with any such claim at its own expense, 2 no admission of liability and no settlement of any claim in a manner adverse to the Indemnified Party shall be made without the approval of the Indemnified Party, acting reasonably, and 3 no admission of liability shall be made by the Indemnified Party without the approval of the Indemnifying Party, acting reasonably, and the Indemnifying Party shall not be liable for any settlement of any claim made without such approval.
In the event that any of the required policies of insurance are written on a claims made basis, then such policies shall be maintained during the entire term of this Agreement and for a period of not less than three 3 years following the termination or expiration of this Agreement.
DRL shall be named as an additional insured under the Commercial General Liability and Products and Completed Operations Liability insurance policies as respects the manufacturing services outlined in this Agreement. Supplier shall furnish certificates of insurance for all of the above noted policies and required additional insured status to DRL within ten 10 days after the Effective Date of the Agreement and upon renewal of any such policies. Mikah shall be named as an additional insured under the Products and Completed Operations Liability insurance policies as respects the Product and completed operations outlined in this Agreement.
DRL shall furnish certificates of insurance for all of the above noted policies and required additional insured status to Mikah within ten 10 days after the Effective Date of the Agreement and upon renewal of any such policies. This Agreement may be terminated at the conclusion of the Initial Term or at any time thereafter by either Party upon six 6 months written notice.
If either Party at any time breaches any of the Material Provisions of this Agreement, the other Party shall have the right to terminate this Agreement with respect to a Product to which the breach relates upon sixty 60 days written notice, whereupon this Agreement shall terminate with respect to such Product, unless the breach complained of is corrected within the said notice period.
In addition, either Party shall have the right to terminate the entire Agreement if it chooses upon a material breach of any term that is not corrected as set forth herein. Except as necessary to permit DRL to sell any Product remaining in the distribution chain, upon any expiration or termination of this Agreement, except as the Parties may otherwise agree in the event and at the time of termination, any and all license rights granted by Mikah to DRL shall automatically and immediately terminate and revert to Mikah free of charge, and free and clear of any liens, security interest or encumbrance.
Mikah shall pay DRL, within sixty 60 days of the effective date of termination, the amount of outstanding Net Loss in proportion to the profit share percentage to which Mikah is entitled.
The provisions of this Agreement which by their terms are to be performed or complied with subsequent to the termination or expiration of this Agreement shall survive such termination or expiration and shall continue in full force and effect in accordance with their respective terms. Except as set forth below or elsewhere in this Agreement, the following provisions of this Agreement shall survive expiration or termination of this Agreement whether terminated pursuant to Article 10 or any other section providing for termination : Sections 3.
Neither Party will be liable to the other Party for any loss or damage due to such cause.
Exhibit This Agreement is made between. Arriani Pharmaceuticals S. The purpose of this Agreement is to grant the Distributor the exclusive right to market, sell and distribute the Product within the Territory as defined in Exhibit A and in accordance with the terms and conditions expressed herein. In this Agreement, each time the following terms are used with initial capitals, their meanings shall be as specified hereunder. License Agreement - Arriani Pharmaceuticals, S. Date: May 21,
The Distributor agrees to also furnish the Company with copies of all agreements, brochures, pamphlets and documents which may relate to the Product.
49+ SAMPLE Distribution Agreement Templates in PDF | MS Word
Exhibit JJC is an operator and franchiser of retail smoothie and juice stores. NOW, THEREFORE, in consideration of the foregoing and in consideration of the covenants, promises, obligations, and agreements of the parties contained in this Agreement and other good and valuable consideration, the receipt and adequacy and sufficiency of which are hereby acknowledged by each party hereto by its execution hereof, it is hereby agreed as follows:. During the term of this Agreement, Distributor shall be the exclusive purchaser, warehouser, and distributor of all Products with the exception of test items, equipment, marketing items and uniforms , as needed, to JJC Stores for the Distribution Territory.
A distribution agreement defines the terms and conditions that a distributor follows for selling products provided by a supplier. This Distribution Agreement the "Agreement" is made on the [Day Ordinal Number] day of [Month], [Year] by and between [Supplier Name] with a principal business address at [Underlined Space for Supplier Business Address, including state and zip code] the "Supplier" and [Distributor Name] with a principal place of business at [Underlined Space for Distributor Business Address, including state and zip code] the "Distributor". The supplier manufactures and sells the Products listed in Paragraph 1 the "Products". The Distributor wants to purchase the Products from the Supplier for resale in the geographic areas defined in Paragraph 2 the "Territory". The Distributor also desires this appointment, subject to the terms and conditions set forth in this Agreement, including any exhibits or schedules attached.
There are several types of distributor agreements, although most contain similar provisions. Which arrangement makes the most sense for your particular business situation? DeLoe, Esq.
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Не успел он набрать международный код, как в трубке раздался записанный на пленку голос: Todos los circuitos estan ocupados - Пожалуйста, положите трубку и перезвоните позднее. Беккер нахмурился и положил трубку на рычаг. Он совсем забыл: звонок за границу из Испании - все равно что игра в рулетку, все зависит от времени суток и удачи.
- И замолчал. - Подумайте, мистер Клушар, - тихо, но настойчиво сказал Беккер.