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DISTRIBUTION AGREEMENT

Distribution Agreement

DISTRIBUTION AGREEMENT | Document Parties: ANGIODYNAMICS INC |  Medical Components Inc You are currently viewing:
This Distribution Agreement involves

ANGIODYNAMICS INC | Medical Components Inc

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Title: DISTRIBUTION AGREEMENT
Governing Law: New York     Date: 10/7/2005

DISTRIBUTION AGREEMENT, Parties: angiodynamics inc ,  medical components inc
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Confidential treatment requested. Confidential

portions of this document have been redacted

and have been separately filed with the Commission.

 

 

Exhibit 10.1

 

DISTRIBUTION AGREEMENT

 

THIS AGREEMENT is effective as of the last date of signature set forth herein and is by and between ANGIODYNAMICS ® , Inc., (hereinafter ‘ANGIODYNAMICS”), a Delaware corporation having a principal place of business at 603 Queensbury Avenue, Queensbury, New York 12804, and Medical Components Inc., (hereinafter “MEDCOMP”), a Pennsylvania corporation, having a principal place of business at 1499 Delp Drive, Harleysville, Pennsylvania 19438.

 

IN CONSIDERATION of the mutual promises contained herein, the parties agree as follows:

 

1.

DEFINITIONS

 

 

1.1

“Territory” as used herein shall mean the entire world except where specifically indicated otherwise.

 

 

1.2

“Products” as used herein shall mean those products as set forth in Exhibits A, B, C, D, E (“hereinafter Exhibits A-E”) attached hereto. Exhibits A-E may be modified from time to time, during the effective period of this Agreement, by the mutual written consent of the parties.

 

 

1.3

“Know-how” as used herein shall include all technology and trade secrets necessary for the manufacture, sale, research and development, and marketing of the Products.

 

 

1.4

“Patent Rights” as used herein shall include any U.S. patent, reissued patent or patent re-examination certificate and any foreign counterparts which have a claim that covers the Products which are or will be licensed and/or assigned to MEDCOMP including pending U.S. Patent Applications, as well as any and all patent rights which are related thereto, and any patent rights acquired in the future by MEDCOMP for any improvements, adaptations, modifications or derivative inventions having a claim that covers the Products, provided that for any such rights which are licensed to or will be licensed to MEDCOMP, MEDCOMP has been granted or will be granted a right to sublicense under such license or a right to assign or otherwise convey the license agreement to third parties.

 

 

1.5

“Trademarks” as used herein includes all trademark(s) and trade name(s) pertaining to the Products and any related trade dress rights.

 

 

1.6

“Intellectual Property Right” as used herein shall include any and to all rights in and to the Products in the form of Know-how, Patent Rights, Trademarks, and copyrights which are owned, licensed or otherwise possessed by MEDCOMP.

 

 

1.7

“Specifications” shall mean the specifications for each of the Products and attached herewith in Exhibits A-E, as they are modified during the effective period of this Agreement by the mutual written consent of the parties.


2.

APPOINTMENT

 

 

2.1

As designated on each of the Exhibits A, B, and E, MEDCOMP hereby grants to ANGIODYNAMICS the sole and exclusive distributorship, together with the right to appoint others, for the Products in Exhibits A, B, and E throughout the Territory. MEDCOMP shall not sell, either directly or indirectly, any of the Products in Exhibits A, B, and E to any other person or entity.

 

 

2.2

As designated on Exhibit C, MEDCOMP hereby grants to ANGIODYNAMICS the sole and exclusive distributorship, together with the right to appoint others, for the Products listed in Exhibit C throughout the United States, and a non-exclusive distributorship for the Products listed in Exhibit C, together with the right to appoint others, throughout the Territory, except for the United States which shall remain exclusive. In the United States, MEDCOMP shall not sell, either directly or indirectly, any of the Products in Exhibit C to any other person or entity.

 

 

2.3

As designated on Exhibit D, MEDCOMP hereby grants to ANGIODYNAMICS a non-exclusive distributorship for the Products listed in Exhibit D throughout the Territory, together with the right to appoint others.

 

 

2.4

For each of the appointments in paragraphs 2.1-2.3, ANGIODYNAMICS shall inform MEDCOMP of its selection of any appointees and MEDCOMP shall have the right to reasonably object to any such appointment.

 

3.

PRICE, PAYMENT, AND ORDERING

 

 

3.1

The price of the Products shall be as set forth in Exhibit A-E attached hereto, as such price is indicated next to each Product. This price includes the cost of sterilization and packaging. Such prices shall be firm for the initial Twelve (12) month period of this Agreement, and thereafter, such prices may be adjusted upon Thirty (3) days notice to ANGIODYNAMICS by no more than Two percent (2%) per year or the U.S. consumer price index which ever is greater. The price of the Products as set forth in Exhibit A-E does not include any applicable sales and use taxes, which MEDCOMP has the legal obligation to pay.

 

 

3.2

Orders for the Products shall be initiated by a written purchase order sent or faxed to MEDCOMP. To facilitate MEDCOMP’s production schedule, ANGIODYNAMICS shall submit purchase orders to MEDCOMP at least Forty-five (45) days prior to the requested date of delivery.

 

 

3.3

ANGIODYNAMICS’ purchase orders, submitted to MEDCOMP with respect to the Products, shall be governed by the terms and conditions of this Agreement.

 

 

3.4

Full payment of the purchase price of the Products shall be net Forty-five (45) days and payment shall be made by check, or other instrument agreed to by both parties. Payment by ANGIODYNAMICS’ rights under Paragraph 6 or as acceptance of the Products delivered.

 

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4.

MINIMUM SALES

 

 

4.1

ANGIODYNAMICS agrees to purchase from MEDCOMP the minimum yearly number of Product units for each set of Products as set forth in Exhibit A-E attached hereto. In the event that ANGIODYNAMICS fails to purchase at least 90% of the annual minimum as set forth on each Exhibit or the adjusted minimums if this contract is extended as set forth in Section 4.3, MEDCOMP, at its sole discretion, may convert the distributorship for those Products set forth as exclusive on that Exhibit for either the Territory or that portion of the Territory that was exclusive to a non-exclusive distributorship. Such remedy shall be MEDCOMP’s sole and exclusive remedy in the event that ANGIODYNAMICS fails to purchase at least 90% of minimums as set forth above.

 

 

4.2

It shall not be considered a material breach by MEDCOMP if they supply at least 90% of the minimum requirements set forth herein.

 

 

4.3

If this Agreement is extended for an additional five-year term pursuant to Section 13.6, the minimum yearly number of Product units for each set of the Products will be 10% higher than the previous years’ sales of each set of the Products.

 

5.

PACKAGING AND SHIPPING

 

 

5.1

All Products shipped pursuant to this Agreement shall be packaged, labeled, and shipped in accordance with ANGIODYNAMICS’ instructions. All freight, insurance, and other shipping expenses, as well as applicable taxes and duties, shall be borne by ANGIODYNAMICS. Each shipping container must be marked to show quantity, order, number, lot number, contents, and shipper’s name. A packing slip showing this information shall be included with the shipment. A Certificate of Compliance shall accompany each lot within the shipment.

 

 

5.2

Title to and risk of loss of the Products shall pass to ANGIODYNAMICS from MEDCOMP at the point of destination, ANGIODYNAMICS’ receiving dock.

 

 

5.3

MEDCOMP agrees to ship the Products with not less than three years remaining on its stated expiration date.

 

6.

SPECIFICATIONS

 

 

6.1

The Products shall meet the Specifications attached herewith in Exhibits A-E. ANGIODYNAMICS reserves all right to return, at MEDCOMP’s sole expense, any Product not meeting said Specifications. ANGIODYNAMICS must inform MEDCOMP within Forty Five (45) days of receipt of Product if it believes that any Product fails to meet the Specification. In the event that MEDCOMP is unable to replace such returned Product with an acceptable Product within Forty-Five (45) days, such failure shall be considered a material breach of this Agreement.

 

3


7.

REGULATORY

 

 

7.1

MEDCOMP shall produce all Products in accordance with all applicable regulatory laws, rules, and regulations. MEDCOMP will permit ANGIODYNAMICS, or its designated representative, to perform vendor audits of MEDCOMP’s facilities and procedures. MEDCOMP will notify ANGIODYNAMICS of any FDA inspections, observations, and/or 483’s. Any observations/483’s shall be given to ANGIODYNAMICS in writing within 30 days of the inspection. Further, MEDCOMP will provide ANGIODYNAMICS with a Certificate of Compliance, a Sterilization Certificate, and certification of non-pyrogenicity for each batch/lot of Products shipped. MEDCOMP will allow ANGIODYNAMICS, or its designated representative, subject to the confidentiality provisions herein, to inspect the Products’ Design History Files and will also allow confidential access to all technical documentation necessary to demonstrate compliance with the European Medical Device Directive. Additionally, MEDCOMP will notify ANGIODYNAMICS of any proposed changes in raw materials, components, processes, or labeling, at least Ninety (90) days prior to such action and must obtain ANGIODYNAMICS’ written approval for such changes, which shall not be unreasonably withheld. MEDCOMP guarantees that no Products sold pursuant to this Agreement are adulterated or misbranded within the meaning of The Federal Food, Drug and Cosmetics Act (hereinafter the “Act”), and further guarantees that no Products sold pursuant to this Agreement are barred from introduction into inter-state commerce under the provisions in Sections 404, 505 or 512 of the Act.

 

 

7.2

All customer complaints for the Products will be processed through ANGIODYNAMICS’ Customer Service Department. Once a complaint has been received, it is the responsibility of ANGIODYNAMICS to forward a copy of the complaint within five (5) working days to MEDCOMP. If MEDCOMP receives such a complaint, MEDCOMP will notify ANGIODYNAMICS within five (5) working days. MEDCOMP agrees to perform an investigation of each customer complaint and forward complaint results in writing to ANGIODYNAMICS within a reasonable time considering the nature of the complaint. ANGIODYNAMICS agrees to complete the complaint file and respond to the customer. MEDCOMP agrees to comply with all applicable regulatory laws, rules and regulations for reporting of customer complaints by manufacturers. ANGIODYNAMICS agrees to comply with all applicable regulatory laws, rules and regulations for the reporting of customer complaints by distributors.

 

 

7.3

Recalls. Each party agrees to notify the other party promptly if any of the Products are the subject of a recall, market withdrawal or correction and the parties shall cooperate in the handling and disposition of such recall, market withdrawal or correction. MEDCOMP shall be responsible for the costs of such recall, market withdrawal or correction, except to the extent that such recall, market withdrawal or correction is due to ANGIODYNAMICS’ improper storage, handling, distribution or marketing of the Products in which case ANGIODYNAMICS shall be responsible for the costs of such recall, market withdrawal or correction.

 

4


8.

LABELS AND LABELING

 

 

8.1

MEDCOMP shall have the obligation to design and produce all labels, labeling, and inserts for the Products, other than the pouch and box labels.

 

 

8.2

ANGIODYNAMICS shall have the obligation to design and produce the pouch and box labels for the Products.

 

 

8.3

ANGIODYNAMICS may waive the obligation to design and produce the pouch and box labels for the Products, if both parties agree in writing that MEDCOMP labels are to be used.

 

 

8.4

Each party shall obtain the other party’s prior written approval for the labels they have designed, prior to production of the same.

 

 

8.5

MEDCOMP shall have the responsibility to apply all labels, including the pouch and box labels to the Products.

 

 

8.6

MEDCOMP agrees that the labeling may include the ANGIODYNAMICS’ trademark.

 

 

8.7

ANGIODYNAMICS agrees that the Products and/or their packaging shall bear, where appropriate, MEDCOMP’s trademarks, and a statutory indication of the patent number or the legend “U.S. patent pending” or “U.S. pat. pending” in the U.S. and any required foreign patent marking where foreign patent rights exist.

 

 

8.8

MEDCOMP shall allow the addition of the ANGIODYNAMICS trademark to all currently published literature and educational materials associated with the Products.

 

9.

WARRANTIES

 

 

9.1

MEDCOMP warrants that the (i) title to all Product conveyed hereunder is good, (ii) the Products delivered hereunder are free from any security interest or other lien or encumbrance, (iii) the Products shall be delivered free of the rightful claim of any third party by way of infringement of any patent or trademark, and (iv) the Products will be manufactured in accordance with the product specifications, (v) the Products are fit for the purposes described in the instructions for use and shall be free any defects that may effect the intended use, (vi) the Products shall be manufactured, produced, and delivered to ANGIODYNAMICS in accordance with all applicable laws, rules, and regulations, (vii) MEDComp agrees to indemnify, defend and hold harmless ANGIODYNAMICS, its customers, and users of the Products from all loss, damages, cost, or expense, including reasonable attorney’s fees, arising from the breach by MEDCOMP of the aforementioned warranties.

 

10.

OPTION FOR FUTURE LICENSE OR TECHNOLOGY TRANSFER

 

 

10.1

In the event that MEDCOMP elects not to continue manufacturing the Products, or in the event that this Agreement is terminated for a failure to supply as set forth in this Agreement, or due to MEDCOMP’s insolvency or bankruptcy, MEDCOMP agrees to negotiate in good faith a royalty-bearing non-exclusive license or sublicense to make, use or sell Products under the Patent Rights to ANGIODYNAMICS, provided such ability and right to license or sublicense is available to MEDCOMP.

 

5


 

10.2

In the event that MEDCOMP ceases manufacturing the Products, to the extent such cessation is within MEDCOMP’s control, MEDCOMP will provide ANGIODYNAMICS with written notice, Six (6) months in advance of the anticipated date of cessation of manufacture.

 

 

10.3

In the event a license or sublicense is successfully negotiated in accordance with Paragraphs 10.1, MEDCOMP agrees to cooperate with ANGIODYNAMICS and to train ANGIODYNAMICS’ personnel on manufacture, design, assembly, quality control and packaging of the Products for a period of Six (6) months at no cost to ANGIODYNAMICS, and to transfer any manufacturing Know-how.

 

11.

IMPROVEMENTS

 

 

11.1

ANGIODYNAMICS shall have the right to develop design improvements for the Products, and if developed solely by ANGIODYNAMICS any associated Intellectual Property rights shall belong solely to ANGIODYNAMICS and such Products shall become part of this Agreement as set forth in paragraph 11.2.

 

 

11.2

In the event that such design improvements are developed by ANGIODYNAMICS, the parties agree to amend this Agreement to add such improvements to the Products as set forth on Exhibit A-E.

 

 

11.3

ANGIODYNAMICS and MEDCOMP shall have the right to cooperate in development of design improvements for the Products. In the event ANGIODYNAMICS and MEDCOMP jointly develop design improvements for the Products, any associated Intellectual Property rights shall belong to ANGIODYNAMICS and MEDCOMP jointly and shall become part of this Agreement and shall be added as improvements to the Products as set forth on Exhibit A-E.

 

 

11.4

MEDCOMP shall have the right to develop design improvements for the Products and in the event that such design improvements are developed solely by MEDCOMP, MEDCOMP shall solely own all Intellectual Property rights to such improvements. The parties agree to amend this Agreement to add such improvements to the Products on Exhibit A-E.

 

12.

INTELLECTUAL PROPERTY

 

 

12.1

MEDCOMP shall retain all of its rights, title and interest in and to its patents, copyrights, trademarks, trade names, and all other industrial and intellectual property. Except as otherwise expressly provided in this Agreement, ANGIODYNAMICS shall have no right, title or interest in any industrial or intellectual property relating to the Products, except to marketing and promotional materials and reports and all marketing data and all intellectual property relating thereto. Nothing herein shall be construed as a license or other grant of rights in any of the Intellectual Property of either party.

 

 

12.2

Validity and Infringement of MEDCOMP’s Patents:

 

 

12.2.1 

In the event ANGIODYNAMICS or MEDCOMP become aware of any actual or threatended infringement of any MEDCOMP patents, that party shall promptly notify the other.

 

6


 

12.2.2 

MEDCOMP shall have the first and exclusive right, but not the obligation, to bring and control any infringement action against any person or entity materially infringing any MEDCOMP Patent Rights directly or contributorily and shall have the first right, but not the obligation, to defend any MEDCOMP Patent Rights against any challenge to the validity and enforceability of that patent in the Courts of the United States or in the United States Patent and Trademark Office or in any foreign jurisdiction. At the request of MEDCOMP, ANGIODYNAMICS agrees to cooperate with MEDCOMP, at MEDCOMP’s sole cost, in any lawsuit on any of the Patent Rights, including being named as a party, if necessary.

 

 

12.2.3 

MEDCOMP shall bear the full cost of any action brought by MEDCOMP regarding its Patent Rights and shall be entitled to all recovery from such lawsuit.

 

13.

TERM AND TERMINATION

 

 

13.1

Subject to earlier termination as provided in this Section 13, this Agreement shall be for a term of Five (5) years.

 

 

13.2

Either party shall have the right to terminate this Agreement by written notice to the other party immediately upon the occurrence of the following:

 

 

13.2.1 

The bankruptcy or insolvency of the other party, or the commencement of any proceedings by or against the other party seeking receivership, trusteeship, bankruptcy, reorganization, assignments for the benefit of creditors or similar proceedings.

 

 

13.2.2 

Failure of the other party to cure any material breach (a failure by AngioDynamics to purchase the minimum requirements of each Product shall not be deemed a material breach for purposes of this Agreement) of this Agreement within Sixty (60) days after written notice of such breach. In the event ANGIODYNAMICS purchases Sixty percent (60%) or less of its minimum requirement for any Product, ANGIODYNAMICS shall lose its exclusivity rights, if any, to that Product. Furthermore, in the event ANGIODYNAMICS purchases Forty percent (40%) or less of its minimum requirement for any product, MEDCOMP shall have the right, upon written notice to ANGIODYNAMICS, to cancel this Agreement as to such Product and make any arrangements MEDCOMP believes is appropriate, in its sole and absolute discretion, to sell such Product through other individuals or entities.

 

 

13.2.3 

Upon the mutual written consent of both parties.

 

 

13.3

ANGIODYNAMICS may terminate this Agreement immediately, if MEDCOMP, for any reason, is unable to supply Products that meet the product Specifications to ANGIODYNAMICS for a period of Ninety (90) days.

 

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13.4

Upon termination of this Agreement, for any reason other than ANGIODYNAMICS’ failure to pay for the Products, MEDCOMP shall honor ANGIODYNAMICS’ orders that were placed prior to the effective date of termination and ANGIODYNAMICS shall pay for such orders and make any other payments due to MEDCOMP pursuant to the terms of this Agreement. Notwithstanding that ANGIODYNAMICS’ rights to purchase the Products for distribution and s


 
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