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AGREEMENT

Distribution Agreement

AGREEMENT | Document Parties: VALLEY FORGE SCIENTIFIC CORP.  | Codman &Shurtleff, Inc. You are currently viewing:
This Distribution Agreement involves

VALLEY FORGE SCIENTIFIC CORP. | Codman &Shurtleff, Inc.

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Title: AGREEMENT
Governing Law: New Jersey     Date: 12/28/2004
Industry: Medical Equipment and Supplies     Law Firm: Schenkman Jennings & Howard, LLC    

AGREEMENT, Parties: valley forge scientific corp.  , codman &shurtleff  inc.
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                                                                   Exhibit 10.12

                                    AGREEMENT

                                    ---------

 

         This AGREEMENT ("Agreement"), dated as of October 1, 2004, by and

between VALLEY FORGE SCIENTIFIC CORP. a Pennsylvania corporation with a business

address of 136 Green Tree Road, Oaks, PA 19456 ("Valley Forge"), and Codman &

Shurtleff, Inc. ("CODMAN") a corporation existing under the laws of

Massachusetts with a business address of 325 Paramount Drive, Raynham, MA 02767.

 

         WHEREAS, CODMAN develops, manufactures, and markets medical

instruments, implants and accessories for the diagnosis and treatment of

conditions affecting the central nervous system;

 

         WHEREAS, Valley Forge develops, manufactures and supplies medical

devices and related instrumentation and accessories used for the bipolar

electrical and radio frequency surgical treatment of bodily tissues and titanium

mesh products related to surgery;

 

         WHEREAS, the parties desire that CODMAN distribute Valley Forge's

Existing Products (as defined below) through December 31, 2005 under the Valley

Forge Patents (as defined below) pursuant to the terms of this Agreement;

 

         WHEREAS, the parties desire to set forth certain other agreements

regarding Valley Forge's New Product (as defined below); and

 

         WHEREAS, the parties desire to agree upon other matters as set forth

herein.

 

 

         NOW, THEREFORE, in consideration of the mutual promises, covenants and

agreements hereinafter set forth, the parties hereto agree as follows:

 

                                   ARTICLE ONE

 

                                   DEFINITIONS

                                   -----------

 

         As used throughout this Agreement, each of the following terms shall

have the respective meaning set forth below:

 

                  "Affiliate" of a party shall mean any entity or person that

directly or indirectly controls, is controlled by or is under common control

with such party. For purposes of this definition, "control" shall mean the

possession, directly or indirectly, of the power to direct or cause the

direction of the management and policies of an entity, whether through the

ownership of voting securities, by contract or otherwise.

 

                                       1

<PAGE>

 

                  "Calendar Quarter" shall mean the calendar quarter customarily

used by CODMAN for internal accounting purposes consisting of approximately

three months in which each of the first two months consists of four weeks and

the third month consists of five weeks.

 

                  "Valley Forge Patents" shall mean (i) all of the Patents as

defined below, (ii) all other patents and applications for patents that cover

the manufacture, use, importation or sale of any Existing Product, in which

Valley Forge (or any Affiliate of Valley Forge) has any rights, any foreign

counterparts thereof, as well as all continuations, continuations-in-part,

divisions and renewals thereof, all patents which may be granted thereon, and

all reissues, reexaminations and extensions.

 

                  "Field" shall mean the practice of neurocranial and

neurospinal surgery.

 

                  "Improvement" shall mean any adaptation, change, redesign,

improvement, modification of any Existing Product (as defined below), the

Specifications (as defined below) therefor, the Raw Materials (as defined below)

or the method or process of manufacture or production of any Existing Product

provided, however, any adaptation, change, redesign, improvement, or

modification of any Existing Product which results in such Existing Product

being indicated for use in applications other than those within the Field shall

not be considered an Improvement. Notwithstanding anything in this Agreement to

the contrary, an Improvement shall not mean the New Product, or any adaptation,

change, redesign, improvement, modification of the New Product.

 

                  "Know-How" shall mean all know-how relating to the

development, manufacture, sale or use of any Existing Product, including,

without limitation, processes, techniques, methods, products, apparatuses,

biological materials and other materials and compositions which are reasonably

related thereto. Notwithstanding anything in this Agreement to the contrary,

Know-How shall not mean any know-how relating to the development, manufacture,

sale or use of the New Product.

 

                  "Manufacturing Costs" shall mean the direct labor, direct

overhead and Raw Materials costs incurred in the manufacture of Existing

Product.

 

                                       2

<PAGE>

 

                  "Patents" shall mean the U.S. Patents set forth on Schedule C,

along with any foreign counterparts thereof, as well as all continuations,

continuations-in-part, divisions and renewals thereof, all patents which may be

granted thereon, and all reissues, reexaminations, extensions, patents of

addition, and any subsequent improvement patents or applications, such

improvement patents and applications being those the practice of which falls

within the claims any of said patents.

 

                  "Existing Products" shall mean the medical devices,

disposables and accessory products indicated for use in the Field as described

in Schedule A attached hereto.

 

                  "New Product" shall mean the New Product as described in

Schedule B, attached hereto.

 

                  "Accessory Products" shall have the meaning set forth in

Schedule A, attached hereto.

 

                  "Medical Device Products" shall have the meaning set forth in

Schedule A, attached hereto.

 

                  "Disposable Products" shall have the meaning set forth in

Schedule A, attached hereto.

 

                  "Raw Materials" shall mean the materials, components, and

packaging required to manufacture and to package any Existing Product in

accordance with the Specifications.

 

                  "Specifications" shall mean the specifications for the design,

composition, product safety assurance, manufacture, packaging, and/or quality

control of any Existing Products the same may hereafter be modified by mutual

agreement of the parties in writing. Schedule D, attached hereto, references the

document that contains the agreed upon Specifications for the Existing Products,

which is made a part hereof.

 

                  "Exclusivity Term" shall have the meaning set forth in Section

10.01, herein.

 

                  "Extended Term" shall have the meaning set forth in Section

10.02, herein.

 

                  "Exclusivity End Date" shall mean March 31, 2005, or such

later date as may be mutually agreed to in writing by CODMAN and Valley Forge.

 

                                       3

<PAGE>

 

                                   ARTICLE TWO

 

                      SUPPLY OF PRODUCT, PRICE, OTHER TERMS

                      -------------------------------------

 

         2.01    Distribution Rights. Valley Forge hereby appoints CODMAN, and

CODMAN hereby accepts appointment, as Valley Forge's exclusive worldwide

distributor of the Existing Products in the Field for the Exclusivity Term of

this Agreement. Thereafter, Valley Forge hereby appoints CODMAN and CODMAN

accepts appointment, as Valley Forge's non-exclusive worldwide distributor of

the Existing Products in the Field for the Extended Term of this Agreement.

Valley Forge understands and agrees that during the term of this Agreement,

CODMAN may utilize its Affiliates to act as distributors hereunder in certain

geographic areas, provided that CODMAN shall at all times remain responsible for

performance of all of its obligations under this Agreement.

 

         (a) The parties acknowledge that Valley Forge develops, manufactures

             and markets through other distributors medical devices and related

             instrumentation indicated for use outside the Field, and that it is

             in the parties' mutual interest to ensure that such other products

             are not used in the Field during the Exclusivity Term. In the event

             Valley Forge becomes aware during the Exclusivity Term that any of

             its other distributors of its medical devices and related

             instrumentation intended for use outside the Field are promoting

             the use of such devices and/or instrumentation in the Field, Valley

             Forge shall take all such reasonable actions as may be permitted by

             law to prevent or discourage such promotion in the Field.

 

         (b) Valley Forge acknowledges that CODMAN and Dr. Leonard I. Malis have

             entered into a trademark/license agreement ("Trademark Agreement")

             for the "Malis" trademark ("Trademark"). On this date, Leonard I.

             Malis and CODMAN have entered into an extension of the Trademark

             Agreement coterminous with the Exclusivity Term and the Extended

             Term. Valley Forge consents to CODMAN using the "Malis" trademark

             in accordance with the terms of the Trademark Agreement as

             extended, and CODMAN consents to Dr. Leonard I. Malis entering into

             an option agreement with Valley Forge and transferring to Valley

             Forge the Trademark on terms substantially similar to the form of

             option agreement, attached as Exhibit A, hereto.

 

                                        4

<PAGE>

 

         2.02    Supply of Product. During the term of this Agreement, Valley

Forge shall supply all product quantities of Existing Products as required by

CODMAN (and its Affiliates), subject to the terms and conditions of this

Agreement, for distribution for use in the Field pursuant to this Agreement.

Each such Existing Product shall be manufactured and packaged by Valley Forge or

its suppliers in accordance with the Specifications.

 

         2.03    Prices.

 

         (a) The initial price (the "Price") for each Existing Product (other

             than sample, special or prototype products) during the term of this

             Agreement is as set forth on Schedule E attached hereto. The Prices

             set forth in Schedule E include all costs of manufacturing and

             packaging in accordance with the Specifications and such Prices are

             F.O.B. Valley Forge's facilities in Philadelphia, PA or Oaks, PA.

 

         (b) The Prices set forth on Schedule E shall remain in effect through

             December 31, 2005.

 

         (c) Valley Forge hereby agrees that it shall use its good faith efforts

             to minimize its Manufacturing Costs of producing the Existing

             Products to the extent it may do so without compromising the

             quality of the Existing Products or compliance with terms of this

             Agreement.

 

         2.04    Forecasts. The parties understand and agree that certain

critical Existing Product components have significant procurement lead times,

and the parties understand and acknowledge that the prices of Existing Products

above the levels set forth in the forecasts will be greater than the prices set

forth in Schedule E, attached hereto. Attached as Schedule F are CODMAN's

forecasts for Medical Device Products and Accessory Products for the period from

October 1, 2004 to December 31, 2005 and forecasts for Disposable Products for

the period from October 1, 2004 to June 30, 2005. On or before March 31, 2005,

CODMAN shall provide to Valley Forge its forecasts for the Disposable Products

for the period from July 1, 2005 to December 31, 2005. If CODMAN does not

provide to Valley Forge its projections for the Disposable Products by March 31,

2005, the projections for the period from July 1, 2005 to December 31, 2005

shall be the same as the forecasts for quantities of Disposable Products for the

immediately preceding six (6) month period. Valley Forge shall be under no

 

                                       5

<PAGE>

 

obligation to supply CODMAN Disposable Products for the period from July 1, 2005

to December 31, 2005 in quantities in excess of 125% over the forecasted amounts

for the immediately preceding six (6) month period. CODMAN will confirm these

projections with the issuance to Valley Forge of its official purchase order.

 

         2.05    Orders. CODMAN shall place any binding orders for Existing

Products by written or electronic purchase order (or by any other means agreed

to by the parties) to Valley Forge. Such purchase orders shall set forth the

desired date of delivery with respect to the Products ordered and shall be

placed at least ninety (90) days prior to such desired date of delivery for all

Medical Device Products and at least sixty (60) days prior to such desired date

of delivery for all Disposable Products and Accessory Products. To the extent

there is any conflict or inconsistency between this Agreement and any purchase

order, purchase order release, confirmation, acceptance or any similar document,

the terms of this Agreement shall govern. Valley Forge shall be obligated to

supply up to 110% of the quantity forecasted pursuant to Section 2.04. Orders in

excess of such 110% shall be subject to acceptance by Valley Forge; provided

that Valley Forge will accept such excess orders to the extent it has, and its

suppliers have the manufacturing capacity to supply them.

 

         2.06    Delivery. All charges for final packaging and transport

packaging are included in the Price. All shipments must be accompanied by a

packing slip that describes the articles, states the purchase order number and

shows the shipment's destination. Valley Forge agrees to promptly forward the

original bill of lading or other shipping receipt for each shipment in

accordance with CODMAN's instructions. Valley Forge further agrees to promptly

render correct and complete invoices to CODMAN, and to accept payment by check

or, at CODMAN's discretion, cash or electronic transfer of funds. All invoices

submitted by Valley Forge shall be payable net within thirty (30) days after the

date of such invoices. The date of invoice with respect to any Existing Product

shall not be earlier than the date of shipment of such Existing Product.

 

         2.07    Shipment. Valley Forge shall ship Existing Products, at CODMAN's

cost to the extent set forth in Section 2.03, to any location chosen by CODMAN

utilizing carriers approved by CODMAN. The risk of loss with respect to all

Existing Products shall remain with Valley Forge until the products to be

shipped are loaded on to the carrier specified by CODMAN. Valley Forge will

package all Existing Products in accordance with the packaging requirements

included in the Specifications.

 

                                       6

<PAGE>

 

         2.08    Minimum Purchase Requirements:

 

         (a) Existing Products. CODMAN shall purchase Existing Products from

             Valley Forge for the period from October 1, 2004 to March 31, 2005

             in the minimum dollar amount of $1 million dollars per calendar

              quarter ("Minimum Dollar Purchase Obligations").

 

         (b) The Minimum Dollar Purchase Obligations shall be proportionally

             reduced on a unit-for-unit product basis to the extent (i) Valley

             Forge is for any reason unable to supply Existing Products in

             accordance with the terms of this Agreement, (ii) the particular

             Existing Product is recalled or withdrawn from the market for

             reasons of product safety, efficacy, reliability or deviation from

             the Specifications, or (iii) a third party infringes any of the

             Patents and such infringement is deemed the cause for the Minimum

             Dollar Purchase Obligations not to be met. The Minimum Dollar

              Purchase Obligations for the particular Existing Product or

             Products shall be reduced to zero in any given year in which the

             Existing Product or Products are the subject of a formal claim

             filed in a proceeding in the U.S. by a third party asserting that

             the manufacture, importation, use or sale of the Existing Product

             or Products infringes the intellectual property rights of a third

             party and will be adjusted prospectively upon final resolution of

             such claim. If the claim is filed in a proceeding outside the U.S.

             for a particular product, then the Minimum Dollar Purchase

             Obligations for the particular Existing Product shall be reduced on

              a proportionate basis based on sales of the particular Existing

             Product in the country where the claim is filed as compared to the

             total worldwide sales of the same Existing Product.

 

                                  ARTICLE THREE

 

                      ADDITIONAL OBLIGATIONS OF THE PARTIES

                      -------------------------------------

 

         3.01    Sales of Existing Products. All business decisions relating to

the sale, price, marketing and promotion of any Existing Product supplied under

this Agreement shall be within the sole discretion of CODMAN. Valley Forge

further agrees that (i) payment by CODMAN to Valley Forge of the Prices set

 

                                       7

<PAGE>

 

forth in Section 2.03 hereof for purchased Existing Product, and (ii) satisfying

the Minimum Dollar Purchase Obligations; shall constitute complete satisfaction

of any duty, whether express or implied, which could be imposed upon CODMAN to

commercially exploit its rights under this Agreement and are accepted by Valley

Forge in lieu of any best efforts obligations on the part of CODMAN, and the

remedies for the failure to fulfill any such obligations shall be limited, as

applicable, to loss of exclusivity, termination or the payment of the Price for

purchased Existing Product as expressly set forth herein.

 

         3.02    Package Labeling. CODMAN shall be responsible for the text and

regulatory compliance of all package labels, labeling and Existing Product

inserts used in connection with the Existing Products. For purposes of this

Agreement the terms "label" and "labeling" shall have the meanings set forth in

Sections 201(k) and 201(m) respectively of the U.S. Federal Food, Drug and

Cosmetics Act.

 

         3.03    Provision of Information by Valley Forge. Valley Forge shall, at

the request of CODMAN, provide CODMAN with the following information relating to

the Existing Products and to the extent reasonably available to Valley Forge, at

no cost to CODMAN:

 

         (i)       provide all relevant information on product safety, efficacy,

                  reliability and performance characteristics;

 

         (ii)      the Device Master Record and Device History Record, as defined

                  in 21 Code of Federal Regulations, Part 820, for the Existing

                  Products and components thereof;

 

         (iii)     copies of all U.S. and foreign regulatory submissions,

                  including any 510(k) submissions for the Existing Products;

 

         (iv)      supply the written text of a technical service manual and user

                  manual for each Existing Product in "print ready" form at no

                  cost to CODMAN. CODMAN will supply Valley Forge with a

                  quantity of technical service manuals and user manuals at its

                  cost and Valley Forge will ship the same with each unit of

                  Existing Product purchased.

 

         3.04    Changes. In no event shall any change in form, fit or function,

safety, efficacy or reliability, or the appearance of an Existing Product

("Significant Change") be made without the prior written approval of CODMAN. If

the parties agree on any such change, they shall modify the Specifications to

reflect the same. Valley Forge further agrees that no significant changes to the

method or process of manufacture or production of any Existing Product or the

Raw Materials shall be made without prior written notification to and approval

of CODMAN. As used in this Section 3.04, the term "significant change" shall

mean any change that (i) results in a change to the Specifications (ii) affects

Existing Product performance, labeling, physical appearance or configuration,

 

                                       8

<PAGE>

 

software (other than debugging or other error correction which does not

otherwise affect on the performance of the software), packaging, or

sterilization processes, (iii) affects Product safety, reliability or integrity

or (iv) requires a submission to or approval from a governmental body. In the

event of any significant change, CODMAN shall have the responsibility to

establish an appropriate qualification protocol, if required by CODMAN, and

CODMAN and Valley Forge shall determine an appropriate inventory level for the

pre-change Existing Product in order to cover on-going requirements during the

qualification process. The parties will negotiate in good faith to determine the

change in the purchase price, if any, which may be required by the change.

 

         3.05    Insurance. Valley Forge agrees to procure and maintain in full

force and effect during the term of this Agreement valid and collectible

insurance policies in connection with its activities as contemplated hereby

which policies shall provide Comprehensive General Liability coverage including

Existing Products and Contractual Liability coverage in an amount not less than

$5 million per occurrence. Such policy shall name CODMAN as an insured or an

additional insured. Upon CODMAN's request, Valley Forge shall provide to CODMAN

certificate of coverage or other written evidence reasonably satisfactory to

CODMAN of such insurance coverage. Such insurance policy shall provide that in

the event such insurance coverage should be materially adversely changed or

terminated for any reason, the insurer thereunder will give Valley Forge and

CODMAN ten (10) days' prior notice. The existence of such coverage shall in no

way limit Valley Forge's liability or obligations hereunder.

 

         3.06    Training. CODMAN shall develop and implement training programs

for its sales representatives and customers with respect to the operation and

maintenance of the Existing Products. Valley Forge shall be responsible for the

technical accuracy of all training materials and shall assist CODMAN in

preparing the technical aspects of such training programs. Valley Forge shall

actively participate in training CODMAN trainers, who will in turn train CODMAN

sales representatives and customers.

 

         3.07    Governmental Registrations. CODMAN shall apply, in its name and

at its cost, for all governmental registrations required for CODMAN to market

Existing Products during the Exclusivity Term as a distributor in those

 

                                       9

<PAGE>

 

countries where CODMAN desires to market Existing Products during the

Exclusivity Term, unless the applicable laws of a particular country require

that such registrations be obtained by and in the name of the manufacturer of

the applicable product, in which event Valley Forge shall apply for such

approvals at CODMAN's cost. Valley Forge shall reasonably cooperate with CODMAN

in its efforts to obtain such approvals. Valley Forge agrees that CODMAN shall

have access to all of Valley Forge regulatory submissions and technical files

for the Existing Products to the extent necessary to exercise its rights or

fulfill its obligations hereunder.

 

         3.08    CODMAN will:

 

         i.      advertise the Existing Products in those medical journals and/or

Direct Mail which in its judgment are best suited for sale of the Existing

Products, a copy of such advertisement will be reviewed by Valley Forge prior to

its release. In disagreements as to marketing or sales content, CODMAN shall

prevail. On matters of technical description or medical use or practice, Valley

Forge shall prevail.

 

         ii.     show the Existing Products at the AANS and CNS and such other

trade shows as mutually agreed upon by CODMAN and Valley Forge.

 

         iii.    CODMAN will review its marketing plan for the Existing Products

with Valley Forge on a semi-annual basis, commencing within forty-five (45) days

of the signing of this Agreement.

 

         3.09    Valley Forge shall:

 

                (a) during the Exclusivity Term provide CODMAN with field

         testing units of the New Product for CODMAN's evaluation and testing;

         provided, however, notwithstanding anything in this Agreement to the

         contrary, except as set forth in Section 3.11, below, CODMAN shall have

         no rights regarding New Product (including without limitation

         distribution or sales rights), except as agreed by Valley Forge in

         writing in Valley Forge's sole and absolute discretion.

 

                (b) use commercially reasonable efforts (i) to enter into a

         lease for a new facility to consolidate its existing Philadelphia and

         Oaks facilities into a single facility; and (ii) to occupy that

         facility by December 31, 2004. During the Exclusivity Term, Valley

         Forge will review with CODMAN from time-to-time the plans to

         consolidate its operations into a single facility, including its

         efforts to sell its existing Philadelphia facility.

 

                                       10

<PAGE>

 

         3.10    During the Exclusivity Term, Valley Forge and CODMAN will

cooperate with each other in good faith to develop mutually agreeable project

plans and schedules for the review and evaluation of the New Product and will

conduct project reviews no less frequently than monthly in order to enable

Valley Forge to complete field testing units for the New Product by the November

30, 2004 target date. CODMAN will conduct its field testing and evaluation of

New Product within ninety (90) days after the date that the field testing units

of the New Product are delivered by Valley Forge to CODMAN, but in no event

later than the end of the Exclusivity Period ("Evaluation Period").

 

         3.11    Limited Right of First Refusal for New Product During the

Exclusivity Term

 

         (a) During the Exclusivity Term, prior to offering the New Product to a

third party distributor to distribute or sell the New Product for use in the

Field, Valley Forge shall offer CODMAN the right of first refusal to market the

New Product in the Field by giving CODMAN a written notice ("New Product

Notice") of the minimum purchase requirements CODMAN's purchase price for the

New Product, and other terms, after which CODMAN shall have a period of thirty

(30) days or until the end to the Exclusivity Term, whichever is earlier, ("New

Product Decision Period") to enter into a distribution agreement for the New

Product under the terms set forth in the New Product Notice or other terms

mutually agreed upon in writing by Valley Forge and CODMAN ("New Distribution

Agreement").

 

         (b) In the event CODMAN (i) gives written notice to Valley Forge of its

decision not to exercise its right of first refusal during the First New Product

Decision Period, or (ii) if CODMAN fails to enter into a New Distribution

Agreement with Valley Forge during the New Product Decision Period, then,

notwithstanding anything in this Agreement to the contrary, Valley Forge may

pursue other distribution opportunities for the New Product in the Field, on

terms that are, in the aggregate, not less favorable to Valley Forge than the

terms specified by Valley Forge in the New Product Notice or contained in the

last subsequent proposal by Valley Forge to CODMAN, if any, and, in the event

that Valley Forge desires to pursue such less favorable distribution

opportunities, then Valley Forge shall be required (each time such situation

 

                                       11

<PAGE>

 

arises during the Exclusivity Term) to give a new notice to CODMAN pursuant to

this Section 3.11 and comply with the right of first refusal set forth herein.

 

         (c) Notwithstanding anything in this Agreement to the contrary, the

right of first refusal set forth in Section 3.11(a) and (b), above shall

terminate at the end of the Exclusivity Term.

 

         (d) Furthermore, notwithstanding anything in this Agreement to the

contrary, the right of first refusal in Section 3.11(a) and (b), above shall not

apply to Valley Forge or any wholly-owned subsidiary marketing or selling the

New Product through its own sales force or through independent sales

representatives. Valley Forge (including any wholly-owned subsidiaries),

however, agrees not to market or sell the New Product in the Field through its

own sales force or through independent sales representatives until the earlier

of the expiration of the Evaluation Period or the end of the Exclusivity Term.

 

                                  ARTICLE FOUR

 

                  QUALITY/DEFECTIVE PRODUCT/INSPECTIONS/TESTING

                  ---------------------------------------------

 

         4.01    Inspections. CODMAN shall have the right, upon reasonable notice

to Valley Forge and during regular business hours, to inspect and audit the

facilities being used by Valley Forge (or any third party) for production and

storage of Existing Products to assure compliance by Valley Forge (and its

suppliers) with (i) all applicable statutes, laws and regulations, including,

without limitation, Quality System Regulations ("QSRs") enforced by the United

States Food and Drug Administration (the "FDA"), (ii) CODMAN Quality Assurance

Policies, (iii) Johnson & Johnson Corporate Quality Assurance Requirements, and

(iv) the terms and provisions of this Agreement. Valley Forge shall within

fourteen days remedy or cause the remedy of any deficiencies which may be noted

in any such audit or, if any such deficiencies can not reasonably be remedied

within such fourteen day period, present to CODMAN a written plan to remedy such

deficiencies as soon as possible; and the failure by Valley Forge to remedy or

cause the remedy of any such deficiencies within such fourteen day period or to

present such a plan within such fourteen day period and then use its best

efforts to remedy or cause the remedy of such deficiencies in accordance with

such written plan, as the case may be, shall be deemed a material breach of this

 

                                       12

<PAGE>

 

Agreement. Valley Forge acknowledges that the provisions of this Section 4.01

granting CODMAN certain audit rights shall in no way relieve Valley Forge of any

of its obligations under this Agreement, nor shall such provisions require

CODMAN to conduct any such audits.

 

         4.02    Acceptance; Disposition of Non-Compliant Product. CODMAN shall

have no obligation to pay for any Existing Product that is subject to such a

claim of non-compliance with the specifications; provided CODMAN shall pay for

Product within 30 days of receipt unless such Existing Product has been rejected

within such 30-day period. Valley Forge shall replace at its own cost and

expense, including reimbursement of freight costs incurred by CODMAN, Existing

Product that fails to comply with the Specifications or other warranties made in

Article Five, which replacement shall constitute CODMAN's sole and exclusive

remedy therefor (but in no way limiting Valley Forge's indemnity obligations

under Section 6.01). CODMAN shall notify Valley Forge of the existence and

nature of any non-compliance with the specifications that comes to its attention

and shall return such non-compliant Existing Product to Valley Forge within

fifteen (15) days after it is rejected by CODMAN. Valley Forge shall have a

reasonable opportunity, not to exceed ten (10) days from receipt of such

Existing Product, to inspect such non-compliant product and provide CODMAN an

explanation of the non-compliance and proposed course of action (i.e. repair

(including the nature of the repair) or replacement of the Existing Product).

The acceptance (or non-rejection) of any Existing Products shall in no way limit

CODMAN's rights under Valley Forge product warranty or for indemnification

hereunder; provided however that Valley Forge shall replace non-compliant

product (i) under this Section 4.02 if found to be non-compliant within


 
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