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LICENSE AND SUPPLY AGREEMENT

Supply Agreement

LICENSE AND SUPPLY AGREEMENT | Document Parties: ULURU INC. | MEDA AB You are currently viewing:
This Supply Agreement involves

ULURU INC. | MEDA AB

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Title: LICENSE AND SUPPLY AGREEMENT
Date: 3/30/2009
Industry: Biotechnology and Drugs     Law Firm: Bingham McCutchen     Sector: Healthcare

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LICENSE AND SUPPLY AGREEMENT

 

dated as of __ November 17, 2008__ between

 

MEDA AB

 

and

 

ULURU Inc.

 


 

 

 

 


 

 

THIS LICENSE AND SUPPLY AGREEMENT (this “Agreement”) is made and entered into as of this __ November 17, 2008___ (the “Effective Date”), between MEDA AB, a corporation organized and existing under the laws of Sweden, and having an address at Pipers väg 2, Box 906 , 170 09 Solna, Sweden (“MEDA”) and ULURU Inc., a corporation organized and existing under the laws of Delaware and having an address at 4452 Beltway Drive, Addison, Texas, 75001, USA (“ULURU”).

 

RECITALS

WHEREAS, ULURU is the owner of the rights to OraDisc™ A (amlexanox) and Aphthasol Paste (5% amlexanox paste) for the prevention and treatment of aphthous ulcers;

 

WHEREAS, On December 23, 1998, MEDA and ULURU entered into 5% Amlexanox Paste License Agreement, whereas MEDA had been granted the rights to register, market, promote, sell and distribute Aphthasol Paste (5% amlexanox paste) in several European countries (hereinafter referred to as the “Old Agreement”);

 

WHEREAS, the Parties intend to extent the territory of the Old Agreement and to add the promotion and distribution rights for OraDisc™ A (amlexanox);

 

WHEREAS, ULURU desires to grant to MEDA, and MEDA desires to obtain from ULURU, an exclusive license to register, promote, market, sell and distribute the Products (as defined below) and an exclusive right to purchase from ULURU and distribute the Products, all under the terms and subject to the conditions set forth herein;

 

WHEREAS, MEDA and ULURU want to terminate the Old Agreement effective as of the Effective Date and enter into this Agreement;

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and for good and valuable consideration the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:

 

 

 

 


 

1.  

DEFINITIONS

 

1.1.  

Definitions.

 

As used in this Agreement, the following capitalized terms have the meanings indicated below:

 

1.1.1.  

 “Affiliate” means, in the case of either Party, any corporation, joint venture, or other business entity which directly or indirectly controls, is controlled by, or is under common control with that Party. The term “control,” as used in this definition, means having the power to direct, or cause the direction of, the management and policies of an entity, whether through ownership of voting securities, by contract or otherwise. Notwithstanding the foregoing, for purposes of this Agreement, the term “Affiliate” does not include entities in which a Party or its Affiliates owns a majority of the ordinary voting power to elect a majority of the board of directors but is restricted from electing such majority by contract or otherwise, until such time as such restrictions are no longer in effect.

 

1.1.2.  

“Batch” means the volume of finished, packaged Products obtained from a validated Manufacturing run.

 

1.1.3.  

“Certificate of Analysis” means the document identifying the results of the Methods of Analysis for a specific Batch of Product in a form agreed to by the Parties in writing but which shall include, without limitation, the applicable Product Batch’s manufacturing date, expiration date, lot number and testing results and data.

 

1.1.4.  

“Confidential Information” means either MEDA Confidential Information, ULURU Confidential Information, or both, as the context requires.

 

1.1.5.  

“Contract Year” means each consecutive twelve (12) month period during the Term, the first of which shall commence on the first day of the calendar month following the date of Launch and end on the first anniversary thereof.

 

1.1.6.  

“Control” means, with respect to any item of information or intellectual property right, the possession, whether by ownership or exclusive license, of the right to grant a license or other right with respect thereto.

 

1.1.7.  

“Effective Date” has the meaning set forth in the Preamble.

 

1.1.8.  

“EMEA” means (a) the European Medicines Evaluation Agency, London, United Kingdom, or (b) any local regulatory agency or governmental entity which fulfills a role similar to the EMEA, or any successor entities thereto.

 

1.1.9.  

“Facility” and / or “Facilities” means any and all facilities regarding the Manufacture of the Products and the supply of the Materials, which are listed in Exhibit B or any subsequent or replacement facilities approved by MEDA.

 

1.1.10.  

“Field” means the prevention and treatment of aphthous ulcers.

 

1.1.11.  

“Force Majeure Event” has the meaning set forth in Article 11.

 

1.1.12.  

“Good Manufacturing Practice” or “GMP” means (a) the then current standards for the manufacture of pharmaceuticals, (b) such standards of good manufacturing practice as are required by the applicable laws and regulations of countries in which the Product is intended to be sold, to the extent such standards are not inconsistent with the then current standards for the manufacture of pharmaceuticals as set forth in the FD&C Act, and (c) any quality requirements set forth in this Agreement or the Quality Agreement attached hereto as Exhibit C .

 

1.1.13.  

“Indemnified Party” has the meaning set forth in Section 8.1.3.

 

1.1.14.  

“Indemnifying Party” has the meaning set forth in Section 8.1.3.

 

1.1.15.  

“Intellectual Property Rights” means Patents, designs, formulae, trade secrets, know-how, industrial models, and technical information Controlled by ULURU and whether now existing or coming into existence during the Term and which are necessary for and/or related to the use or distribution of the Products.

 

 

 


 

1.1.16.  

“Invention” means any new or useful method, process, manufacture, compound or composition of matter, whether or not patentable or copyrightable, or any improvement thereof arising during the Term with respect to the Products, its Manufacture and/or use.

 

1.1.17.  

“Launch” means the date on which the respective Product is sold by MEDA for the first time to a Third Party for commercial distribution in the Territory.

 

1.1.18.  

“Major Countries” shall mean (i) initially France, Germany, Italy, and United Kingdom and (ii) potentially later Spain, provided that ULURU had re-acquired the rights back from Esteve S.A., Spain, in accordance with Section 3.1.5.

 

1.1.19.  

 “Manufacture,” “Manufactured” or “Manufacturing” means all activities involved in the production of the Products, including, without limitation, the preparation, formulation, finishing, testing, packaging, storage and labeling of the Products and the handling, storage and disposal of any residues or wastes generated thereby.

 

1.1.20.  

 “Materials” means all materials, including, without limitation, all raw materials, ingredients, packaging supplies and labels, required for the Manufacture of Products.

 

1.1.21.  

“MEDA” has the meaning set forth in the Preamble.

 

1.1.22.  

“MEDA Confidential Information” means all information, specifications, know-how and data pertaining to MEDA’s business disclosed to ULURU, its Affiliates or its Third Party manufacturer hereunder, including, without limitation, marketing and sales plans, artwork, formats, equipment, logos, drawings, customer lists, regulatory filings, correspondence with the EMEA or any other Regulatory Authority, clinical study data, analytical data, operating procedures and all ordering and sales information.

 

1.1.23.  

“MEDA Trademarks” means any trademarks, trade name, trade dress, slogan, logo, or similar item selected by MEDA for use in connection with the Products, including but not limited to the trademark Apthasol®, as listed in Exhibit J .

 

1.1.24.  

“Methods of Analysis” means the methods of analysis for the Products which are mutually agreed upon in writing between the Parties and, on a date to be mutually agreed upon by the Parties, attached as an exhibit to this Agreement.

 

1.1.25.  

“Net Sales” means, with respect to the Product, the gross invoiced sales amount of the Products sold by MEDA or its Affiliates to non-affiliate Third Parties, after deduction of the following items, to the extent that such deductions are reasonable and actually allowed, taken or incurred, and (provided that such items do not exceed reasonable and customary amounts in the country in which the sale occurred): (a) trade and quantity discounts, net of any give-backs received by MEDA in return; (b) refunds, rebates, governmental rebates, retroactive price adjustments, service allowances and broker’s or agent’s commissions; (c) credits or allowances given for rejection or return of previously sold Products or for wastage replacement actually taken or allowed; and (d) any tax, duties or government charge levied on the sale of Product and borne by MEDA and/or its Affiliates (excluding national, state or local taxes based on income). Such amounts shall be determined from the books and records of MEDA and its Affiliates maintained in accordance with generally accepted accounting principles, consistently applied. Sales of the Products by and between a Party and its Affiliates for further distribution to a Third Party are not sales to Third Parties and shall be excluded from Net Sales calculations for all purposes.

 

1.1.26.  

“Old Agreement” shall have the meaning as set fort in the Preamble of this Agreement

 

1.1.27.  

“Party” or “Parties” means either MEDA, ULURU or both, as the context requires.

 

1.1.28.  

“Patents” shall mean (a) the patents listed in Exhibit D and (b) any and all patents, patent applications, patent disclosures awaiting filing determination, patent divisionals, continuations, continuations-in-part, reissues, re-examinations, renewals and extensions thereof Controlled by ULURU during the Term, within the Territory, which are necessary for the Manufacture, use or distribution of the Products.

 

1.1.29.  

“Person” means any natural person, corporation, general partnership, limited partnership, limited liability company, limited liability partnership proprietorship, other business organization, trust, union, association or governmental authority.

 

1.1.30.  

 “Products” shall mean the Products listed in Exhibit A

 

1.1.31.  

 “Recall” means any action by any Party to recover title to or possession of any Product sold or shipped to Third Parties or any action to prevent or interrupt the sale or shipment by a Party of the Products to Third Parties that would have been subject to recall if it had been sold or shipped.

 

1.1.32.  

“Regulatory Approval” means all consents, permits, approvals, licenses, authorizations, qualifications, notices or orders that are issued or granted by Regulatory Authorities which are required for the manufacture, marketing, promotion, pricing and sale of the Products in a country within the Territory.

 

1.1.33.  

“Regulatory Authority” means any domestic or foreign, federal, national, regional, state, county, city, municipal, local or other administrative, legislative regulatory or other governmental authority, agency, department, bureau, commission, or council involved in the granting of Regulatory Approval for the Products in the Territory.

 

1.1.34.  

“Rolling Forecast” has the meaning set forth in Section 3.4.

 

1.1.35.  

“Seizure” means any action by the EMEA or any other Regulatory Authority to detain or destroy the Products or prevent the release of the Products.

 

1.1.36.  

“Specifications” means the specifications for the Products as set forth in the Exhibit E or in the Quality Agreement.

 

1.1.37.  

“Supply Failure” shall have the meaning as set forth in Section 3.7.2.

 

1.1.38.  

“Term” means, with respect to each country in the Territory, the period commencing on the Effective Date and ending upon the expiration of the last-to-expire patent within the Patents in such country, except as and if sooner terminated in accordance with Article 9.

 

1.1.39.  

“Territory” means,

(a) initially:

 

(aa)

Countries of the Old Agreement, which are: Denmark, Sweden, Norway, Finland, Estonia, Lithuania, Latvia and

(bb)           New countries, which are

 

(i)

European Union countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, France, Germany, Hungary, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, United Kingdom, and

(ii)           Non-European Union Countries: Switzerland, Turkey and

 

(iii)

Russia and CIS Markets: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Moldova, Russia, Tajikstan, Ukraine, Uzbekistan and Kyrgyzstan

 

and (b) potentially later Spain, Greece and Portugal provided that ULURU had re-acquired the rights back from Esteve S.A., Spain, in accordance with Section 3.1.5, and any other countries the Parties may agree on to add to this Agreement.

 

1.1.40.  

“Third Party” means any Person other than MEDA, ULURU and their respective Affiliates.

 

1.1.41.  

“Trademarks” means all ULURU trademarks OraDisc™.

 

1.1.42.  

“ULURU” has the meaning set forth in the Preamble.

 

1.1.43.  

“ULURU Confidential Information” means all information, specifications (including, without limitation, the Specifications), know-how and data pertaining to the Products and ULURU’s business or its Manufacturing operations disclosed to MEDA or its Affiliates, Third Party manufacturers or distributors hereunder, including, without limitation, all information, Specifications, know-how and data related to the design, implementation, performance and Manufacture of the Products, and any correspondence with the FDA, EMEA or any other Regulatory Authority, clinical study data, analytical data, or operating procedures.

 

1.2.  

Construction of Certain Terms and Phrases.

 

Unless the context of this Agreement otherwise requires, (i) words of any gender include each other gender; (ii) words using the singular or plural number also include the plural or singular number, respectively; (iii) the terms “hereof,” “herein,” “hereby” and derivative or similar words refer to this entire Agreement; (iv) the terms “Article” or “Section” refer to the specified Article or Section of this Agreement; and (v) Article and Section headings shall not affect the meaning or construction of any provision of this Agreement.

 

 

 


 

 

2.  

TERMINATION OF THE OLD AGREEMENT

 

2.1.  

MEDA and ULURU hereby terminate by mutual agreement the Old Agreement effective as of the Effective Date.

 

2.2.  

The Parties hereby agree that neither Party shall have any rights and/or obligations towards the respective other Party resulting from the Old Agreement and/ or its termination.

 

 

3.  

SUPPLY

 

3.1.  

Grant of License / Expansion of the Territory.

 

3.1.1.  

Subject to the terms and conditions of this Agreement, ULURU hereby grants to MEDA (a) the exclusive right and sub licensable license in the Field under ULURU’s Intellectual Property Rights to market, offer for sale, sell, distribute and import products, including the Products, in the Territory, (b) the exclusive right and sub licensable license in the Field under ULURU’s Intellectual Property Rights to use the Products in the Territory, provided that such right and license is limited to such use as is necessary for MEDA to market, offer for sale, sell, distribute and import and, subject to the terms and conditions set forth in Section 3.8, Manufacture the Products in the Territory, and (c) a exclusive right and sub licensable license to use the Products and all information and Intellectual Property Rights with respect thereto (including, without limitation, data, studies and clinical trials) solely for the purpose of obtaining Regulatory Approvals for the Products. Except as expressly granted herein, ULURU retains all rights in the Intellectual Property Rights and the Products.

 

3.1.2.  

Except as specifically provided to the contrary in Section 3.1.1, the license granted in Section 3.1.1 shall not be construed (a) to effect any sale of ULURU´s Intellectual Property Rights or any other proprietary ULURU technology; (b) subject to the terms and conditions set forth in Section 3.8, to grant any license relating to ULURU’s methods of formulating, fabricating and Manufacturing the Products; (c) to grant MEDA any rights in or to the use of the Intellectual Property Rights by implication or otherwise. MEDA shall mark or have marked all containers or packages of the Products in accordance with the patent marking laws of the jurisdiction in which such units of Products are to be used or distributed.

 

3.1.3.  

Upon expiration of the Term in any country due to (i)the expiration of the last-to-expire patent within the Patents in such country or (ii) due to a termination of the Agreement for cause by MEDA in accordance with the provisions of Section 3.7.3, 9.4 and/or 9.5, MEDA shall have a non-exclusive, transferable, timely unrestricted license to those licenses set forth in Section 3.1.1, provided that MEDA will pay to ULURU the royalties in accordance with Articles 3.1.3 a)- d) of this Agreement:

 

 

a)

In consideration for the license granted by ULURU to MEDA as set out above in Article 3.1.3, MEDA shall pay to ULURU a royalty of 5 % (five percent) on Net Sales of the Products.

 

 

b)

MEDA will pay to ULURU the royalties quarterly (meaning any calendar quarter ending on 31st March, 30th June, 30th September or 31st December) within 30 (thirty) days after the end of the relevant calendar quarter. The currency of the royalty payment shall be EURO. Each royalty payment shall be accompanied by a statement in a form as set forth in Article 3.9.3 d) of this Agreement.

 

 

c)

The rights and obligations of the Parties as to ULURU´s right to inspect and examine MEDA´s books - as laid down in Article 6.5.2 and 6.5.3 of this Agreement shall - apply accordingly.

 

 

d)

It is understood that MEDA´s obligation to pay royalties to ULURU shall cease on a product by product basis upon the expiration of the last-to-expire patent within the Patents in such country.

 

3.1.4.  

MEDA is free to decide whether (i) to use the Trademarks in the countries of the Territory or (ii) to register, at MEDA’s expense, and to use alternative MEDA Trademarks for the promotion, distribution and sale of the Products.

 

 

a)

Trademarks

In case MEDA decides to use the Trademarks and not to register and use the MEDA Trademarks the following shall apply:

 

On request of MEDA, ULURU agrees to register – at ULURU´s own costs – in the respective countries of the Territory the Trademark Ora Disc.

 

Subject to the terms and conditions of this Agreement, ULURU hereby grants to MEDA an exclusive, non-transferable (except in accordance with a permitted assignment of this Agreement under Section 14.3) license in the Field to use the Trademarks solely in connection with the Manufacture, promotion, marketing, sale and distribution  of the Products under this Agreement, within the Territory. Based on the information provided by ULURU, MEDA acknowledges that ULURU is the exclusive owner of the Trademarks and all associated goodwill and registrations. MEDA agrees that it has no rights to use the Trademarks except for the right to use the Trademarks as provided for in this Agreement and all uses of the Trademark by MEDA, and the associated goodwill, shall inure solely to the benefit of ULURU.

 

MEDA further agrees that upon the termination or expiration of this Agreement, all right to use the Trademarks provided to MEDA hereby shall revert fully to ULURU.

 

Except as consistently with this Agreement with respect to the Products, MEDA shall not (a) use the Trademark as part of, or in conjunction with, any other names or Trademarks without ULURU’s prior written approval; (b) use the Trademarks or any confusingly similar marks, terms or designs, except as expressly authorized in this Section 3.1.4; (c) attempt to register any such Trademarks, terms or designs; (d) take any actions inconsistent with ULURU’s ownership of the Trademark and any associated registrations, or attack the validity of the Trademark, ULURU’s ownership thereof, or any of the terms of this Section 3.1.4; (e) use the Trademark in any manner that would indicate MEDA is using such Trademark other than as a licensee of ULURU; nor (f) assist any Affiliate or Third Party to do any of the same.

 

 

b)

MEDA Trademarks

ULURU agrees that MEDA is the exclusive owner of the MEDA Trademarks and all associated goodwill and registrations. ULURU shall have no rights to use the MEDA Trademarks except for the right to use the Trademark as provided for in this Agreement.

 

ULURU further agrees that upon the termination or expiration of this Agreement, all right to use the MEDA Trademarks hereby shall revert fully to MEDA.

 

 

 


 

3.1.5.  

ULURU will provide commercially reasonable efforts to re-acquire from Esteve SA, Spain the exclusive rights for the Manufacture, marketing, promotion, sale and distribution of the Products in Spain, Greece and Portugal. ULURU will promptly inform MEDA once the rights had been re-acquired from Esteve SA. In such a case, the parties agree to extend the Territory and to add Spain, Greece and Portugal to this Agreement. The Parties will stipulate the extension of the Territory in an amendment to this Agreement. To avoid any misunderstandings, the license payments applicable for Spain mentioned in Exhibit I are subject to ULURU´s successful re-acquisition of the Product rights for Spain, Greece and Portugal.

 

3.2.  

Registration of the Products / Regulatory Approvals

 

3.2.1.  

At MEDA’s sole expense, MEDA agrees to make and maintain all Regulatory Approvals for the Products from the Regulatory Authorities in the countries of the Territory.

 

3.2.2.  

ULURU will provide MEDA with all documentation which is necessary for the registration process and the obtaining of the Regulatory Approvals, including but not limited to a certificate of pharmaceutical product (“CPP”) and the US dossiers of the Products. ULURU will use commercially reasonable efforts to assist MEDA in the obtainment of the Regulatory Approvals.

 

3.2.3.  

If MEDA decides not to register OraDisc™ A (amlexanox) in one of the Major Countries, the rights to the respective Product (and only to this Product) in the respective country granted by ULURU according to Section 3.1 shall revert to ULURU.

 

To avoid any misunderstandings, for any other countries other than the Major Countries, MEDA is free to decide whether to make and /or maintain the Regulatory Approvals or not.

 

3.2.4.  

Any Regulatory Approval shall become, if legally permitted in the respective country of the Territory, the sole property of MEDA. MEDA shall be (if legally permitted in the respective country of the Territory) the holder of the Regulatory Approvals.

 

Upon termination and/or expiration of this Agreement for whatever reason, ULURU shall transfer the Regulatory Approvals (if due to legal regulations in a country of the Territory ULURU must be holder of the Regulatory Approval) to MEDA or any Third Party designated by MEDA.

 

3.3.  

Manufacture.

 

3.3.1.  

Subject to Section 3.4, ULURU shall Manufacture and deliver the Products to MEDA in such quantities and at such times as ordered by MEDA in accordance with this Agreement. During the Term, ULURU shall maintain the resources necessary to Manufacture the Products and shall provide, at its own expense, all Materials and labor necessary to do so.

 

3.3.2.  

ULURU may not transfer its Manufacturing and supply obligations under this Agreement to any Third Party without MEDA’s prior written consent. In any case, ULURU is solely responsible towards MEDA for the fulfillment of all of ULURU’s Manufacturing and supply obligations under this Agreement.

 

3.3.3.  

MEDA herewith approves the Third Party manufacturer of ULURU mentioned in Exhibit B .

 

3.3.4.  

If requested by MEDA, ULURU shall be responsible for (a), at MEDA’s cost and expense, supplying to MEDA, prior to the commencement of Manufacturing of the Product, a full scale validation Batch and the data reasonably requested by MEDA (including, without limitation, the final Product formulation, the processing requirements from start to finish for all production, the validated analytical methods, the Specifications and test method (both chemical and physical) for all elements of the disc component and the Product through the finished production of the Products and the validation protocols and schedules for processes, equipment, cleaning and packaging) and MEDA shall reimburse ULURU for ULURU’s actual, reasonable, out-of-pocket costs for the supply of such Batch and data, (b) at MEDA ’s cost and expense, scale-up, validation and stability of the Products for commercial production of the Products, including, without limitation, bulk production of the benzocaine gel, production of the mucoadhesive disc and development and validation of a mutually acceptable package configuration, (c) cooperating with MEDA with respect to the obtaining by MEDA of any Regulatory Approvals required to be obtained by MEDA with respect to the marketing, sale, offering to sell, importing and/or distribution of the Product, and (d) providing to MEDA complete Batch records for all validation Batches and, on an annual basis, providing one representative full Batch record.

 

3.4.  

Forecasts.

 

At least four (4) months prior to Launch, MEDA shall submit to ULURU a forecast of the quantity of the Products that MEDA anticipates ordering from ULURU prior to MEDA’s anticipated Launch of Products. MEDA shall submit to ULURU a forecast of the quantity of the Products that MEDA anticipates ordering from ULURU during the twelve (12) month period (broken down by month) following Launch and MEDA shall update such forecast on a rolling twelve (12) months basis every month thereafter (each, a “Rolling Forecast”). MEDA shall place purchase orders for at least the quantity of the Products specified in the first three (3) months of each such Rolling Forecast and the remaining nine (9) months shall be a non-binding good faith estimate. Except as set forth in this Section 3.4, MEDA shall not be required to order any fixed minimum quantity of the Products or any quantity of the Products, notwithstanding any forecast or prior course of dealing.

 

 

 


 

3.5.  

Orders and Delivery.

 

MEDA shall place its firm orders for the Product with ULURU by submitting a purchase order, at least ninety (90) days prior to the delivery date requested therein, which sets forth (a) the quantity of the Product ordered for delivery; and (b) the delivery date for that order. Any such purchase order which is in accordance with the terms and conditions of this Agreement shall be deemed to be accepted by ULURU.

 

For all other purchase orders placed by MEDA, unless ULURU notifies MEDA in writing within fifteen (15) days of receipt of a purchase order that it is unable to deliver the Product in accordance with such purchase order, ULURU shall be deemed to have accepted such purchase order as a binding order. If ULURU notifies MEDA that it is unable to fill a purchase order that is not in accordance with the terms and conditions of this Agreement, it shall indicate the portion of such purchase order ULURU cannot supply by the requested delivery date and specify alternate delivery dates; provided that in the event that MEDA delivers a purchase order less than ninety (90) days prior to the requested delivery date, ULURU shall use commercially reasonable efforts to meet such requested delivery date despite the shortened lead time, and ULURU will not be in breach of its obligations hereunder if, despite such commercially reasonable efforts, ULURU is not able to meet such requested delivery date with respect to such order. MEDA may cancel or modify any firm purchase order (in whole or in part) at any time prior to the delivery for any quantity of Products for which Manufacturing has not been completed pursuant to such purchase order at the time that notice of cancellation or modification is received by ULURU; provided that if Manufacturing has commenced but not completed pursuant to such firm purchase order, MEDA shall reimburse ULURU for Material and labor costs in respect of any works-in-progress pursuant to such cancelled or modified purchase order (or part thereof) at the time notice of cancellation or modification is received by ULURU; and provided, further, that MEDA shall reimburse ULURU for the actual, reasonable out-of-pocket cost of any other Material purchased by ULURU to fill a cancelled purchase order (or part thereof) that are unique to the Product and cannot within a reasonable period of time otherwise be used in ULURU’s operations.  All Products shall be delivered F.O.B. the Facility and in accordance with MEDA’s instructions.  Title, possession and risk of loss shall pass to MEDA upon delivery of Products to MEDA’s designated carrier at the Facility’s loading dock.  The provisions of this Agreement shall prevail over any inconsistent statement or provisions contained in any document related to this Agreement passing between the parties hereto including, but not limited to, any purchase order, acknowledgment, confirmation or notice.

 

3.6.  

Shelf Life.

 

ULURU shall schedule Manufacturing operations so that all of the Products delivered has the latest expiry date possible, and in no event shall any Products be delivered to MEDA with an expiry date less than the maximum established expiry date (as set forth in the Specifications) less three (3) months. If Product is delivered to MEDA whose expiry date does not conform to the requirements set forth in this Section 3.6, ULURU shall promptly, at its sole expense, replace the non-conforming Product.

 

3.7.  

Supply Failures.

 

3.7.1.  

It is of essence to this Agreement that ULURU delivers the Products at the date stated in the purchase order. In the event that ULURU fails to deliver the Products on or before the delivery date specified in the applicable purchase order, ULURU or its Affiliates shall notify MEDA of such delay and the Parties shall consult in good faith to determine the period of such inability to supply such Product.

 

3.7.2.  

If (i) MEDA reasonably determines that such or any other inability to so supply a Product will continue for more than 90 (ninety) days, or (ii) if ULURU fails to supply any of MEDA´s purchase orders for Product and fails to cure such failure within 60 (sixty) days after the requested delivery date therefore (each of (i) and (ii) shall be referred to as a “Supply Failure”), then MEDA may, at its option either (x) agree to have ULURU supply the undelivered Product at a future date agreed upon the Parties or (ii) have up to 100 (hundred) % supplied by a secondary supplier of such Product as provided for in Article 3.8 below.

 

In any event ULURU shall use commercial reasonable efforts to resume the Manufacture as promptly as possible. In the event of a Force Majeure, the Parties will work in good faith to try and re-establish supply of Products as soon as possible.

 

3.7.3.  

If ULURU continues to be delayed with the delivery of the Products for a period of six (6) consecutive months, MEDA has, without any time restriction, the right to terminate this Agreement.

 

 

 


 

3.8.  

Secondary Supplier:

 

3.8.1.  

MEDA shall have the right to establish and maintain secondary supplier (s) for all Products (in finished form). MEDA and UULURU shall jointly select and agree on a secondary supplier(s), provided however that if the Parties can not agree on a secondary supplier, then MEDA shall be entitled to appoint a secondary supplier at its sole discretion.

 

3.8.2.  

ULURU shall cooperate with MEDA in the transfer of copies of the ULURU Confidential Information, technology and know- how necessary to Manufacture the Products to MEDA and/or its designated secondary supplier (s), (b) deliver to MEDA copies of such drawings, specifications, and other information in ULURU’s possession as may be necessary to Manufacture the Products or cause the Products to be Manufactured and (c) grant to MEDA a limited license in the Field under ULURU’s Intellectual Property Rights during the Term of this Agreement to Manufacture, make, or have made for MEDA’s distribution of the Product in the Territory, the Products; provided that to the extent that such technology and know-how constitutes ULURU Confidential Information (or any information constitutes Confidential Information of ULURU’s Third Party manufacturer) it shall be subject to the provisions of Article 10 and MEDA’s designated secondary supplier shall be required to enter into a confidentiality agreement with ULURU containing substantially the same terms as Article 10; and further provided that all items provided under clauses (a) and (b) above will be subject to the license granted pursuant to clause (c).

 

3.8.3.  

Subject to Section 3.8.1 following the establishment of any secondary supplier hereunder, MEDA may obtain from such secondary supplier such portion of its supplier requirements with the respect to the Product as is necessary to maintain such secondary supplier’s regulatory qualification, but in no event more than 10% of MEDA´s total requirements for the Products. Product procured until this section 3.8.3 will be subject to a royalty of 5% of Net Sales in the Territory.

 

3.8.4.  

Notwithstanding the provisions of Section 3.8.3 above, but subject to Section 3.8.1 above, MEDA shall have the right to obtain from such secondary supplier(s) up to 100% of its supply requirements with respect to any Products in the event (a) of expiration of the Term of this Agreement or (b) MEDA terminates the Agreement with respect to such Product pursuant to Article 3.7.4, 9.4 and 9.5 of this Agreement, (c) in the event of a Supply Failure occurs with respect to such Product.

 

3.9.  

Marketing, Promotion and Distribution .

 

3.9.1.  

ULURU agrees that MEDA shall have only the obligation to market, promote, sell and distribute OraDisc™ A (amlexanox) in the countries of the Major Countries, Belgium, the Netherlands and in Turkey, provided that, nothing shall require MEDA to continue to market or sell the Products in any of these countries during a period of time that MEDA determines, in its sole judgment, that such Product is reasonably likely to be Subject to adverse regulatory or legal action, or infringe any intellectual property right of any Third Party in such country.

 

3.9.2.  

MEDA agrees to Launch in addition OraDisc™ A (amlexanox) in the countries of the Major Countries, Belgium, the Netherlands and in Turkey, within 6 (six) months after Regulatory Approval has been granted, provided that ULURU has delivered MEDA with Products as laid down in the respective purchase order.

 

If OraDisc™ A (amlexanox) will not be launched in the countries of the Major Countries, Belgium, the Netherlands and in Turkey within 6 (six) months after Regulatory Approval has been granted, then ULURU will give MEDA the right to remedy for another 4 (four) months. If Launch of the Products is not effected in this additional 4 (four) months period, then the rights to the respective Product (and only to this Product) in the respective country granted by ULURU according to Section 3.1 shall revert to ULURU.

 

To avoid any misunderstandings, for any other countries than the countries of the Major Countries, Belgium, the Netherlands and Turkey, MEDA is free to decide whether to launch, market, promote, sell and distribute the OraDisc™ A (amlexanox) or not. With regard to Aphthasol Paste (5% amlexanox paste) MEDA is to decide whether to launch, market, promote, sell and distribute it or not

 

3.9.3.  

Subject to Section 3.9.1 – 3.9.2 above, MEDA agrees

 

a) to market, sell and distribute the Products in accordance with the terms of this Agreement.

 

b) that all promotion and selling activities are to be undertaken by MEDA at its own cost and expense and without right of reimbursement therefore.

 

c) to provide to all customers in the Territory customer support relating to the Products.

 

d) to remit on April 15 th , July 15 th , October 15 th and January 15 th of each calendar quarter to ULURU a true, detailed and accurate report, in units and in value, of all sales of Products and samples in the Territory in the preceding calendar quarter.

 

3.9.4.  

ULURU agrees to support MEDA, as far as possible for and available within ULURU, in the promotion, marketing, sale and/or distribution of the Products in the Territory. Any costs related to such support will be borne by MEDA. If possible (i.e. where marketed by ULURU’s partners e.g. USA), ULURU will provide MEDA with examples of promotional material from its sub-licensees and distributors.

 

 

 


 

3.10.  

Supply of Samples

 

As soon as practicable after the Effective Date, the Parties will discuss in good faith the terms and conditions (including but not limited the quantities and prices) regarding ULURU´s obligation to supply MEDA with samples of the Products.

 

3.11.  

Clinical trials / Clinical Data

 

3.11.1.  

If (i) the Parties mutually agree to conduct further clinical trials and/or (ii) if a clinical trial is required for regulatory approval purposes, ULURU will contribute fifty (50%) per cent towards the cost of the respective clinical trial.

 

3.11.2.  

MEDA shall have the right to use and reference all clinical and other technical data generated by ULURU and ULURU’S licensees relating to the Products. ULURU and its licensees shall have the right to use and reference all clinical and other technical data generated by MEDA relating to Products.

 

3.12.  

Additional Responsibilities

 

3.12.1.  

MEDA shall be responsible, at MEDA’s cost and expense, for any consumer product testing and commercialization of the Products, including, without limitation, all sales and marketing activities related to the Products and the design of all Product packaging and related artwork, and the design of all labeling.

 

3.12.2.  

MEDA shall retain, at its own expense a selling and service organization with adequate experience, ability and training for purposes of marketing and selling the Products in the Territory.

 

 

 

 


 

4.  

COMPLIANCE, QUALITY AND ENVIRONMENTAL

 

4.1.  

Compliance with Law.

 

ULURU shall conduct all Manufacturing hereunder in a safe and prudent manner, in compliance with all applicable laws and regulations (including, without limitation, those dealing with occupational safety and health, those dealing with public safety and health, those dealing with protecting the environment, and those dealing with disposal of wastes), and in compliance with all applicable provisions of this Agreement. ULURU shall obtain and maintain all necessary Regulatory Approvals with respect to the Manufacture and supply of the Products to MEDA. To the extent necessary for the Regulatory Approval of the Products, ULURU shall permit the inspection of its premises and the Facilities by Regulatory Authorities and shall supply all documentation and information requested by MEDA or such Regulatory Authority to obtain or maintain Regulatory Approval of the Products.

 

4.2.  

Manufacturing Quality; Storage.

 

4.2.1.  

All Products shall be Manufactured by ULURU at the Facilities using Materials and processing aids free of animal derived materials. ULURU shall sample and analyze all Materials upon receipt to ensure that such Materials are unadulterated, free of defects and meet the applicable Specifications therefore. ULURU shall take all necessary steps to prevent contamination and cross contamination of Products.

 

4.2.2.  

The Products shall be unadulterated and free from contamination, dilutents and foreign matter in any amount and in accordance with the Product specifications and generally accepted pharmaceutical standards. ULURU shall perform the quality control tests (both when the Product is in-process and when it is finished) with respect to the Products in accordance with the Methods of Analysis, the cost of such to be included in the price hereinafter specified. ULURU shall promptly, upon completion of such tests, deliver to MEDA a copy of the record of such tests performed on, and a Certificate of Analysis for, each Batch of Product. ULURU shall deliver a representative sample from each Batch of Product to MEDA’s designated representative by the date reasonably specified by such representative.

 

4.2.3.  

Within sixty (60) days of the Effective Date, each of the Parties shall execute and deliver the Quality Agreement substantially in the form of Exhibit C and as mutually agreed to by the parties.  Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement.  Prior to shipment, the Products shall be stored at all times in conditions at least as favorable as those set forth on the Product’s label, or in accordance with conditions reasonably specified by MEDA.

 

4.3.  

Testing by MEDA.

 

MEDA may test the Product samples in accordance with the applicable Methods of Analysis. If the analysis of any Product performed by or for MEDA differs from ULURU´s analysis of the same Batch, MEDA shall advise ULURU and ULURU and MEDA agree to consult with each other in order to explain and resolve the discrepancy between each other’s determination. If, after good faith attempt by the Parties to do so, such consultation does not resolve the discrepancy, an independent, reputable laboratory as mutually agreed by the Parties shall repeat the applicable Methods of Analysis on representative samples from such Batch provided by both MEDA and ULURU. The costs of the independent laboratory referred to above shall be borne by (a) MEDA if such laboratory determines that the Product conforms to the Specifications or (b) ULURU if such laboratory determines that the Product does not conform to the Specifications. If so requested by MEDA in writing, ULURU shall promptly send a new Batch of the Product (of similar quantity as to the amount of such Product being analyzed as set forth above) to MEDA. MEDA shall not be obligated to pay for any of the Product (and if MEDA has paid for such Product ULURU shall promptly reimburse MEDA for the cost of replacing such Product, including, without limitation, related costs such as testing and transportation costs) that such laboratory determines does not conform to the Specifications, but shall be obligated to pay for any new Batch of Product that is sent as specified above; provided that MEDA must destroy (and certify destruction of) such non-conforming Product.

 

4.4.  

Samples and Record Retention.

 

ULURU shall retain records and retention samples of each Batch of the Products as required by the applicable laws, but for at least thirty-eight (38) months after the expiration date of that Batch and shall make the same available to MEDA upon request. Retention samples shall only be destroyed after the required holding period; provided that in the event that MEDA provides written notice to ULURU during such retention period (at least thirty-eight (38) month) that it desires ULURU to retain such retention samples for a longer period of time, then ULURU shall comply with such request until notified by MEDA that the sample need no longer be retained. During and after the Term of this Agreement ULURU shall reasonably assist MEDA with respect to any complaint, issue or investigation relating to the Products.

 

 

 


 

4.5.  

Inspection.

 

ULURU shall give access to representatives of MEDA, at all reasonable times during regular business hours, to the Facilities and any other facility in which Products are Manufactured, tested, packaged and/or stored, and to all Manufacturing records with respect to the Products, for the purpose of inspection. MEDA shall have the right while at any such Facility to inspect and copy (provided that to the extent that such copies constitute ULURU Confidential Information (or Confidential Information of ULURU´s Third Party Manufacturer) they shall be subject to the provisions of Article 10) records and Regulatory Approvals solely to evaluate work practices and compliance with all applicable EMEA and other Regulatory Authority laws and regulations, occupational health and safety, and environmental laws and regulations, GMP and warehousing practices and procedures. The conduct of (or right to conduct) any inspection under this Section 4.5 does not impose upon MEDA responsibility or liability for the operation of the Facility. Such inspection shall be conducted after prior written notice to ULURU, will be conducted in a manner that is not disruptive to ULURU’s operations, and shall not be more frequent than is reasonable.

 

4.6.  

Adverse Drug Events / Pharmacovigilance Agreement.

 

4.6.1.  

Each Party shall fully, accurately and promptly provide the other Party with all data known to it at any time during the Term of this Agreement or thereafter, which data indicate that any Product is or may be unsafe, lacks utility, or otherwise does not meet the Specifications.

 

4.6.2.  

Within sixty (60) days of the Effective Date, each of the Parties shall execute and deliver the Pharmacovigilance Agreement substantially in the form of Exhibit G and as mutually agreed to by the parties. Each Party agrees to perform its respective obligations under the Pharmacovigilance Agreement in accordance with such agreement.

 

4.7.  

Recalls and Seizure.

 

4.7.1.  

Each Party shall keep the other Party promptly and fully informed of any notification or other information whether received directly or indirectly which might result in the Recall or Seizure of the Products. If either Party determines that it is necessary to Recall any Product, it shall immediately notify the other Party and, prior to commencing any Recall, the Parties shall consult with one another to determine whether or not a Recall is necessary. If it is mutually agreed that a Recall is necessary (or if MEDA determines, in its sole discretion, that a Recall is necessary), then the Parties shall meet and determine the manner in which the Recall is to be carried out and review any instructions or suggestions of the applicable Regulatory Authorities. MEDA and ULURU shall effect the Recall in the manner agreed upon between the Parties in as expeditious a manner as possible and in such a way as to cause the least disruption to the sales of any Product and to preserve the goodwill and reputation associated with the Product. In any such situation, MEDA shall have the right to make all final decisions regarding such Recall.

 

4.7.2.  

In the event that a Recall results from any cause or event arising from ULURU’s breach of Sections 4.1, 4.2, 4.4, 4.6. 4.8 or the representations set forth in Sections 7.2.1, 7.2.4 or 7.2.5 and/or the defective Manufacture, storage or handling of the Products by ULURU (excluding defects relating to packaging or labeling supplied by or prepared at and in accordance with the direction of MEDA), ULURU shall be responsible for all expenses of the Recall incurred by MEDA and ULURU shall promptly replace such Product at no additional cost to MEDA consistent with directions received from the appropriate Regulatory Authority. In the event that a Recall results from any cause or event arising from defective Manufacture, storage, handling or distribution of the Products by MEDA or its Affiliates, distributors or contractors (including but not limited to defective Manufacture, storage, handling or di


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