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ZANAFLEX SUPPLY AGREEMENT

Supply Agreement

ZANAFLEX SUPPLY AGREEMENT | Document Parties: ACORDA THERAPEUTICS INC | ELAN PHARMA INTERNATIONAL LIMITED You are currently viewing:
This Supply Agreement involves

ACORDA THERAPEUTICS INC | ELAN PHARMA INTERNATIONAL LIMITED

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Title: ZANAFLEX SUPPLY AGREEMENT
Date: 1/25/2006

ZANAFLEX SUPPLY AGREEMENT, Parties: acorda therapeutics inc , elan pharma international limited
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Exhibit 10.27

 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

ELAN PHARMA INTERNATIONAL LIMITED

 

AND

 

ACORDA THERAPEUTICS, INC,

 


 

 

ZANAFLEX SUPPLY AGREEMENT

 


 



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

THIS SUPPLY AGREEMENT (this “Agreement” ) is made on July 21, 2004 (the “Effective Date” )

 

BETWEEN:

 

(1)            ELAN PHARMA INTERNATIONAL LIMITED, a company incorporated in Ireland (registered no. 222276) (“Elan”); and

 

(2)            ACORDA THERAPEUTICS, INC., a Delaware corporation whose registered office is at 15 Skyline Drive, Hawthorne, NY 10532 (“Buyer”).

 

RECITALS:

 

(A)           Pursuant to that certain Asset Purchase Agreement between Buyer and Elan Pharmaceuticals, Inc. ( “EPI” ), dated July 21, 2004 (the “Purchase Agreement” ), Buyer acquired (among other assets) the rights and authorisations necessary to market and sell the Products (as defined below) in the Territory (as defined in the Asset Purchase Agreement).

 

(B)           Elan has agreed to manufacture and supply the Products to Buyer, and Buyer has agreed to purchase the Products for onward commercial supply on the terms and conditions set out in this Agreement.

 

NOW IT IS HEREBY AGREED AS FOLLOWS:

 

1.             INTERPRETATION

 

1.1           In this Agreement:

 

“Affected Item” shall have the meaning given to such term in Clause 10.3;

 

“Affected Obligation” shall have the meaning given to such term in Clause 20.1;

 

“Affected Party” shall have the meaning given to such term in Clause 20.1;

 

“Affiliate” shall mean, with respect to any person or entity, any other person or entity which Controls, is Controlled by or is under common Control with such person or entity;

 

“Alternate Manufacturer” shall have the meaning given to such term in Clause 11.4;

 

“Beneficiary” shall have the meaning given to such term in Clause 13.8.2;

 

“Business Day” shall mean a day other than a Saturday or Sunday or public holiday in England and Wales, and Ireland;

 

“cGMP” shall mean current Good Manufacturing Practice under the applicable laws and regulations in the United States, Ireland and the European Union;

 



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

“Confidential Information” shall have the meaning given to such term in Clause 15.1;

 

“Control” means (a) ownership (directly or indirectly) of at least fifty percent (50%) of the shares of stock entitled to vote for the election of directors in the case of a company or corporation; or (b) the ability (directly or indirectly) otherwise to direct and control the actions of a person or entity.

 

“Covenantor” shall have the meaning given to such term in Clause 13.8.2;

 

“Disclosing Party” shall have the meaning given to such term in Clause 17.1;

 

“Due Date” shall have the meaning given to such term in Clause 9.4;

 

“Elan’s Facility” shall mean Elan’s manufacturing facility located at Monksland, Athlone, Co. Westmeath, Ireland or Elan’s Affiliate’s manufacturing facility located at Gainesville, Georgia, U.S.A., or such other manufacturing facility as Elan may from time to time specify (provided that any facility so specified has received all required Facility Licences and Elan has provided Buyer with advance notice sufficient to amend its NDA to include such facility if Elan intends to use a facility other than the one located at Monksland, Athlone, described above);

 

“Ex Works” and “EXW” shall have the meaning as such term is defined in the ICC Incoterms, 2000, International Rules for the Interpretation of Trade Terms, ICC Publication No. 560;

 

“Facility Licences” means all required licenses, approvals, permits and authorizations required by any Governmental Authority or law or regulation to manufacture, package or store Products, or, to the extent required for Elan to perform under this Agreement, to ship or export Products;

 

“Force Majeure Event” means an event beyond the control of the Affected Party which makes the Affected Party’s performance of an obligation impossible (or such an event that makes such performance so impractical as to be reasonably to be considered impossible) including, without limitation, strike, lock-out, labour dispute, act of God, war, armed conflict, terrorism, riot, civil commotion, malicious damage, explosion, earthquake, fire, flood, storm or other extraordinary adverse weather conditions.

 

“Governmental Authority” shall mean each governmental and regulatory body, agency, department or entity, whether or not located in the Territory, which regulates, directs or controls commerce in or with any territory or location;

 

 shall mean the Irish consumer price index or such other index as may replace it from time to time; or if there is no replacement, such published Irish index as Elan in its discretion considers to be the closest comparator to the same;

 

“Initial Term” shall have the meaning given to such term in Clause 11.1;

 

2



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

“Knowledge” of a particular fact or other matter means:  (i) with respect to any individual; (A) the actual knowledge of such individual concerning such fact or other matter; and (B) the knowledge that a prudent individual would be expected to discover or otherwise become aware of in the course of conducting a reasonable investigation concerning the existence of such fact or other matter; and (ii) with respect to Elan or Buyer, the Knowledge concerning such fact or other matter of (1) the officers of such party, (2) the directors of such party, and (3) the senior managers of such party with responsibility for, or supervision of, the relevant matters; provided that under no circumstances shall Knowledge of Elan include any knowledge not actually known to such persons but imputed to such persons or Elan due to its or its Affiliates’ relationship with Novartis Pharma AG (“Novartis”) or its representatives; and provided, further, that none of such persons shall have any obligation as a result of entering into (or any provision of) this Agreement, the Purchase Agreement or any related Agreement to make any inquiries of Novartis or its representatives regarding any matter.

 

“Loss” shall mean any loss, liability, or cost (including reasonable attorneys’ fees and expenses) which is incurred by a party;

 

“Medical Claim” shall have the meaning given to such term in Clause 13.7;

 

“Minor Deficiencies and Delays” shall mean (i) shortfalls that are consistent with industry accepted standards, but not to exceed 10% of the amount ordered (ii) delays in delivery of the Products not exceeding 30 days from the delivery date or such other period of delay as may be agreed between the Parties;

 

“Monthly Forecast Report” shall have the meaning given to such term in Clause 4.1.1;

 

“Production Licence” shall have the meaning given to such term in Clause 11.4;

 

“Products” means pharmaceutical products containing tizanidine as their active pharmaceutical ingredients and having a multi-particulate capsule formulation currently approved by the FDA pursuant to NDA No. 21-447 to be marketed in the Territory.

 

“Product Specifications” shall mean the specifications for the Products contained in the relevant Regulatory Approvals issued by the authorities in the Territory, and such additional or amended specifications for such Products as may be effected under the terms of this Agreement;

 

“Regulatory Application” shall mean any application for a Regulatory Approval, which is filed in the Territory following the Effective Date, including any supplements or amendments thereto;

 

“Regulatory Approval” shall mean the final approval required from a governmental regulatory authority to market a Product in the Territory, and any other approval which is required to market or sell such Product or otherwise necessary for Buyer to perform under this Agreement or otherwise handle the Products;

 

3



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

“Relevant Claim” shall have the meaning given to such term in Clause 13.8;

 

“Renewal Term” shall have the meaning given to such term in Clause 11.1;

 

“Serious Failure to Supply” shall mean that in a period of a calendar year, for reasons other than Force Majeure, a shortage of tizanidine caused by events or third parties not under the control of Elan, or the default of Buyer, Elan fails on at least two consecutive occasions to supply Buyer’s properly forecasted and ordered requirements of the Products in accordance with the terms of this Agreement, except for Minor Deficiencies and Delays, and the cumulative shortfall for such calendar year attributable to such failure(s) is at least 35% of the aggregate amount properly forecasted and ordered from Elan for delivery in such calendar year; provided that, for purposes of this definition the timely supply of Products that breach the representations and warranties made in Clause 13.2 (excluding such Products with nonlatent defects) will be deemed not to be a failure to supply Buyer’s properly forecasted and ordered requirements of the Products in accordance with the terms of this Agreement;

 

“Specified Delivery Date” shall have the meaning given to such term in Clause 4.3;

 

“Technical Agreement” shall have the meaning given to such term in Clause 3.9;

 

“Technological Competitors” shall mean those entities, including any entities that are subsidiaries or successors in interest to such entities, set out in Schedule 3;

 

“Term” shall mean the Initial Term plus any applicable Renewal Term;

 

“Territory” means the United States of America, its territories and possessions and the Commonwealth of Puerto Rico;

 

“VAT” means;  (a) any tax imposed in compliance with the Sixth Directive of the Council of the European Economic Communities (77/388/EEC); and (b) any other tax of a similar fiscal nature, whether imposed in a member state of the European Union in substitution for or in addition to such tax, or imposed elsewhere;

 

“VAT Amount” shall have the meaning given to such term in Clause 10.2; and

 

“$” and “US$” shall mean United States Dollars.

 

1.2           In this Agreement a reference to:

 

1.2.1        the singular includes the plural and vice versa;

 

1.2.2        a “person” includes a reference to a corporation, corporate body, association or partnership;

 

1.2.3        any reference to a “Clause” or “Schedule” , unless the context otherwise requires, is a reference to a clause or schedule of this Agreement; and

 

4



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

1.2.4        any person shall (where appropriate), in respect of any provisions relating to VAT, be deemed at any time when such person is a member of a group for the purposes of section 43 to 43C of the Value Added Tax Act 1994 (or in relation to a jurisdiction other than the United Kingdom, such legal term or concept as most closely corresponds to it) to include a reference to the representative member (or in relation to a jurisdiction other than the United Kingdom, such legal term or concept as most closely corresponds to it) of such group at such time.

 

1.3           The headings of this Agreement are for ease of reference only and shall not affect its construction or interpretation.

 

1.4           In this Agreement, the expressions “include” , “includes” and “including” shall be construed without limitation.

 

2.             EXCLUSIVE SUPPLY

 

2.1           During the Term, subject to Clause 11.4, (Buyer shall purchase all of its (and its Affiliates) requirements of the Products in the Territory exclusively from Elan, and Elan shall supply all such Products under the terms of this Agreement.

 

3.             REGULATORY MATTERS

 

3.1           Following the transfer of the Regulatory Approvals to Buyer pursuant to the terms of the Purchase Agreement, Buyer shall (at its own expense) be responsible for obtaining and maintaining all Regulatory Approvals for the Products with the appropriate Governmental Authority.  Subject and pursuant to the provisions of the Purchase Agreement and Interim Services Agreement between EPI and Buyer, Elan shall provide all information and assistance reasonably requested by Buyer needed to transfer and obtain such Regulatory Approvals.

 

3.2           Each of Elan and Buyer shall, without delay, provide to the other party such copies of all Regulatory Approvals, Regulatory Applications, Facility Licenses and communications with any Governmental Authority to the extent necessary for such other party to comply with its obligations under this Agreement.

 

3.3           Elan shall, at Elan’s expense, be responsible for obtaining and maintaining any and all export or import licences or clearances relating to the raw materials and any other intermediary products contained in the Products, together with any and all Facility Licenses.  Elan shall provide Buyer copies of all such Facility Licenses at Buyer’s request.  Elan shall ensure that each Elan Facility complies with all laws, regulations and licensing requirements applicable to the manufacture of Products in compliance with the Product Specifications and cGMP.  At the request of Buyer, Elan shall take the steps necessary to qualify its Affiliate’s Gainesville, Georgia, U.S.A. facility to manufacture the Product, including but not limited to obtaining all required Facility Licenses; provided that

 

5



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

all reasonable costs of Elan, its Affiliates or its consultants actually incurred in connection with such qualifications shall be borne by Buyer (as long as such costs are approved by Buyer in advance, such approval not to be unreasonably withheld or delayed).

 

3.4           Buyer shall promptly provide to Elan the packaging and related artwork for the Products, which packaging and artwork must comply with the relevant Regulatory Approvals.  Buyer shall be responsible for granting final approval of the pre-press proofs of such artwork.

 

3.5           Buyer shall be responsible for obtaining and maintaining any necessary export or import licences or clearances in respect of the Products.  Elan shall provide to Buyer reasonable assistance and any documents in its possession which are reasonably necessary for that purpose.

 

3.6           Each party shall notify the other party as soon as possible (and in no event later than 48 hours) of any notification received by it from a Governmental Authority to conduct an inspection of the facilities used hereunder in the development, manufacturing, packaging, storage or handling of the Products.  Each party shall promptly provide to the other party copies of all correspondence with a Governmental Authority relating to any such notification or inspection received or sent by it to the extent that such correspondence relates to the Products.  Each party shall have a duty to reasonably cooperate with the other party with respect to such inspections at such other party’s facilities.

 

3.7           Upon reasonable request, Elan shall make that portion of its facility where the Products are manufactured, tested or stored, including all record and reference samples, available for inspection:

 

3.7.1        upon reasonable notice and during normal business hours, by Buyer’s duly qualified employee or, with the consent of Elan (not to be unreasonably withheld or delayed), by Buyer’s duly qualified agent or contractor; or

 

3.7.2        by a relevant Governmental Authority.

 

An inspection under Clause 3.7.1 shall be limited to determining whether there is compliance with cGMP and other requirements of applicable law.

 

3.8           To the extent that any or all of the raw materials or intermediary products contained in the Products are not produced by Elan, Elan shall ensure that such materials or products are suitable for manufacturing the Products in compliance with applicable Regulatory Approvals, Facility Licenses and the Product Specifications and meet all other applicable legal and regulatory requirements.

 

3.9           As soon as is practicable after the Effective Date.  Elan and Buyer shall enter into a mutually-agreeable technical agreement (the “Technical Agreement”) relating

 

6



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

to quality assurance, acceptance testing and other requirements to be agreed by the parties.

 

4.             FORECASTS AND ORDERS

 

4.1           In order to permit Elan to allocate its manufacturing capacity and to assist Buyer with its sales and marketing, Buyer shall provide Elan with bona fide written forecasts of its requirements for each of the Products as follows:

 

4.1.1        By thirty (30) days after the Effective Date, and thereafter each calendar month not later than the 23rd of the month, an 18-month forecast (commencing at the beginning of the following month), broken down by month (each, a “Monthly Forecast Report” ); and

 

4.1.2        not later than 1 July in each year, a two-year forecast, broken down by year.

 

4.2           The aggregate amount of Products forecasted to be required in the first twelve (12) months of each Monthly Forecast Report shall, unless otherwise agreed by Elan, not increase or decrease by more than twenty-five percent (25%) as compared to the first twelve (12) months of the forecast three months prior; provided, however, that until there exists a Monthly Forecast Report from three months prior to the then-current Monthly Forecast Report, the initial Monthly Forecast Report shall be used for purposes of such comparison.

 

4.3           Buyer shall be bound to order one hundred percent (100%) of the forecast required quantities of the Products in each respective month of the period of five (5) months immediately following each Monthly Forecast Report, but otherwise forecasts shall not be binding.  With respect to such orders, Buyer shall submit to Elan a written purchase order for such required quantities of Products, specifying the order quantity and the date on which delivery of the order is required (the “Specified Delivery Date,” which shall in no event be earlier than one hundred fifty (150) days after the date of Elan’s receipt of such written purchase order).  For the avoidance of doubt, the parties acknowledge and agree that, notwithstanding anything to the contrary contained in this Agreement, other than pursuant to the preceding two sentences Buyer shall not be obligated to place any minimum number of orders under this Agreement.

 

4.4           Elan shall not be obligated to supply Products in excess of Buyer’s requirements as forecast in accordance Clauses 4.1, 4.2 and 4.3.

 

4.5           Notwithstanding Clauses 4.1, 4.2, 4.3 and 4.4, Elan will use its commercially reasonable efforts to fulfill Buyer’s requirements in excess of forecasted amounts.

 

4.6           The order quantity shall be in whole number multiples of the minimum batch size of the Products, which minimum batch size shall be as set out in Schedule 1;

 

7



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

provided, however, that upon the request of Buyer, Elan will discuss with Buyer in good faith the reduction of minimum batch sizes set out in Schedule 1 (and any related amendment to Schedule 1); and provided, further, that all reasonable costs of Elan, its Affiliates or its consultants actually incurred in connection with the reduction of such minimum batch sizes shall be paid by Buyer (as long as such costs are approved by Buyer in advance, such approval not to be unreasonably withheld or delayed).  Elan shall have the right to refuse to fulfil any amount of an order which does not conform with the provisions of this Clause 4.6.  Where Elan in its sole discretion fulfils any order which does not conform with the provisions of this Clause 4.6, the fulfilment of such order by Elan shall not affect Elan’s right to refuse to fulfil any subsequent order which does not conform with the provisions hereof.

 

4.7           Buyer hereby agrees that it shall not use Products delivered to Buyer in bulk capsule form for packaging into finished Products for commercial sale.

 

4.8           To the extent that at any time during the Term Buyer notifies Elan of its intention to sell finished Products that Buyer is then holding in inventory as “safety stock”, (a) all then current purchase orders shall remain in place, and (b) Elan agrees to discuss in good faith with Buyer the modification of the Monthly Forecast Report most recently submitted by Buyer (including disregarding the provisions of Clause 4.2 with respect thereto).

 

4.9           The terms of this Agreement are hereby incorporated by reference into each written purchase order for Products submitted by Buyer and accepted by Elan.  In the event of any conflict between an order or other written instructions and this Agreement, the terms of this Agreement shall prevail.

 

5.             SUPPLY OF THE PRODUCTS

 

5.1           Elan shall supply the Products requested in each written purchase order by the Specified Delivery Date (subject to the 30-day cure period specified in Clause 11.2.1).

 

5.2           Each Product supplied by Elan to Buyer shall:

 

5.2.1        be in final market packaging in accordance with written standards agreed by the parties from time to time;

 

5.2.2        be Ex Works Elan’s Facility;

 

5.2.3        be free from any liens or encumbrances;

 

5.2.4        conform to, and be manufactured in accordance with, the relevant Product Specifications and all applicable laws and regulations, including applicable cGMP;

 

8



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

5.2.5        be in suitable packaging in a sealed tamper-evident container and labelled in accordance with Buyer’s reasonable requirements communicated to Elan, in particular as required pursuant to any Regulatory Approval and so as to permit safe storage and transport; and

 

5.2.6        be accompanied by a certificate of analysis and a certificate of release, in each case in a form conforming to industry standards as mutually agreed between Elan and Buyer.

 

6.             CHANGES TO PRODUCT SPECIFICATIONS

 

6.1          If:

 

6.1.1        changes to the Product Specifications are required by law or by any Governmental Authority; or

 

6.1.2        Buyer reasonably requests changes to the Product Specifications;

 

Elan shall promptly implement any such changes at Buyer’s sole cost (such cost to include but not be limited to Elan’s internal and external costs relating to changes to artwork and labeling and changes to raw materials, intermediary products and components, in each case whether such costs are out-of-pocket costs or write-off charges (to the extent such write-off charges are actually incurred by Elan and Elan has attempted in good faith to avoid such write-off charges by making other use of the applicable materials, products or components); provided, that Elan shall provide Buyer with advance notice of such changes and the estimated costs thereof and Buyer shall have the opportunity to discuss with Elan any of such changes or costs prior to such changes being implemented for up to two (2) weeks after Buyer receives such notice; and, provided, further, that with respect to then-outstanding purchase orders submitted by Buyer pursuant to Clause 4.3, to the extent that applicable law or any Governmental or Regulatory Authority does not allow Elan to manufacture and deliver to Buyer, or Buyer to sell, Products ordered under such purchase orders, Elan shall be permitted to delay delivery of Products ordered thereunder for an amount of time equal to the actual delay in making the changes required by changes in Product Specifications caused by compliance with this Clause 6.1 (it being understood and agreed by Buyer that it shall accept Products ordered under such purchase orders despite such Products being manufactured to Product Specifications that do not reflect the changes required by this Clause 6.1, to the extent that applicable law or any Governmental or Regulatory Authority allows Elan to manufacture and deliver to Buyer, and Buyer to sell, such Products).  Otherwise, changes shall only be made to the Product Specifications by agreement between the parties.

 

9



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

7.             DISPUTES AS TO SPECIFICATIONS

 

7.1           All claims for failure of any Product to conform to the Product Specifications must be made by Buyer in writing within sixty (60) days following delivery, except in the case of latent defects.  Claims for latent defects, not discovered during the routine testing protocol (which is to be agreed between the parties reasonably and in good faith), shall be made in writing within forty-five (45) days of discovery.  Except as described in the preceding sentence, failure to make timely claims in the manner prescribed in this Clause 7.1 shall constitute acceptance of the delivery.

 

7.2           Where Products which have been delivered breach the representations and warranties made in Clause 13.2 (and Clause 7.1 has been complied with) and such non-conformity is attributable to acts or omissions of Elan:

 

7.2.1        they shall be reworked (to the extent permitted by applicable law) or replaced at Elan’s cost within ninety (90) days of the receipt by Elan of the non-conforming Products; and

 

7.2.2        Elan shall reimburse Buyer in respect of the costs incurred by Buyer in relation to any testing, handling, destruction or return of the Products.

 

Notwithstanding Clause 11.2.1, no cure period shall apply with respect to Products described in Clause 7.2 other than that set forth in Clause 7.2.1.  Other than as expressly set forth elsewhere in this Agreement in Clause 13.6, and with respect to Serious Failures to Supply and Product recalls, Buyer shall have no remedies in respect of Elan having supplied Products that breach the representations and warranties made in Clause 13.2 other than as set out in this Clause 7.2.

 

7.3           In the event of an unresolved dispute:

 

7.3.1        as to conformity of a Product with the relevant Product Specifications pursuant to Clause 7.1 or 8.3; or

 

7.3.2        pursuant to clauses 8.5 or 13.4,

 

the parties shall appoint an independent first-class laboratory or other appropriate, independent expert to undertake the relevant testing, and its findings shall be conclusive and binding upon the parties.  If the parties fail to agree on the appointment of an independent first-class laboratory or expert, as appropriate, within thirty (30) days after the parties first discuss such appointment, the parties agree that an independent party designated by Elan and an independent party designated by Buyer shall together select a mutually-acceptable, appropriate, independent expert.  Such independent expert shall undertake the relevant analysis and/or testing and report its findings within a reasonable time of

 

10



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

appointment, which findings shall be conclusive and binding upon the parties.  All costs relating to this process shall be borne solely by the unsuccessful party.

 

8.             ADVERSE EVENTS AND PRODUCT RECALL

 

8.1           Each party shall, without delay, give notice to the other of any occurrence that involves:

 

8.1.1        any complaint about the safety, quality, packaging or effectiveness of a Product manufactured or supplied under this Agreement, including a claim for death or injury following administration of such Product (that is allegedly related to the administration of such Product); and

 

8.1.2        any other matter in connection with a Product manufactured or supplied under this Agreement or arising out of this Agreement that must be reported to a Governmental Authority.

 

8.2           The parties agree that within sixty (60) days following the Effective Date, representatives of each party with responsibility for the safety, surveillance and pharmacovigilance of the Products shall meet to develop detailed procedures regarding the format, timing and content of the safety information to be exchanged between the parties, and shall meet periodically thereafter to update the procedures.

 

8.3           If a party:

 

8.3.1        is notified by a Governmental Authority that a recall of a Product is required, requested or otherwise advisable; or

 

8.3.2        establishes a need to recall a Product for non-conformity with the Product Specifications,

 

it shall promptly give to the other party notice of the same with full details.  Notwithstanding any dispute between the parties as to whether the Product complies with the Product Specifications, the recall shall commence but such dispute shall be resolved in accordance with Clause 7.3.

 

8.4           Unless otherwise agreed or unless Elan elects to take over and perform the recall of the Product pursuant to Clause 8.6.2, Buyer shall take the lead/coordinating role in any recall of the Product in a commercially reasonable manner, and Elan shall afford all reasonable assistance to Buyer in respect of such recall.  A joint recall administration team shall be established to support Buyer in such role with an equal number of nominated individuals from each party participating.  A final report shall be completed by the recall administration team and delivered promptly to both parties.

 

11



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, have been separately filed with the Commission.

 

 

8.5           The costs of a recall of the Product, including the cost of replacement quantities of such Product, shall be borne by Buyer unless (a) the recall arises from Elan’s supply of Product that breach the representations and warranties made in Clause 13.2 or from the negligent acts or omissions of Elan in manufacturing the Product, and (b) subject to Clause 13.6, Buyer could not have discovered such failure or acts or omissions prior to the sale of the Product by exercising reasonable diligence in conducting acceptance testing pursuant to the Technical Agreement, in which case Elan shall bear the actual costs of the recall; provided that each party hereby agrees to use commercially reasonable efforts to minimize any costs relating to any recall of the Product that may be borne by the other party.  If the parties are unable to agree who should bear the cost of the recall, the dispute shall be settled in the manner set forth in Clause 7.3.

 

8.6           In the event that Elan is required to bear the costs of any recall of the Product in accordance with Clause 8.5, Elan shall:

 

8.6.1        reimburse Buyer for all reasonable and actual costs and expenses which Buyer incurs in connection with such recall; and

 

8.6.2        be entitled (but not obliged) to take over and perform the recall of such Product.

 

9.             PRICE AND PAYMENT

 

9.1           The price of the Products shall be:

 

9.1.1        until the first anniversary of the Effective Date, the price set out in Schedule 1;

 

9.1.2        thereafter, (and subject to Clause 9.2) at such price as Elan notifies to Buyer from time to time, provided that during the Term (including the Initial Term and any Renewal Term(s)) price increases for the Products shall be limited to the percentage increase in the Index, as compared to the most recent price adjustment.

 

9.2           In addition to any price increases pursuant to Clause 9.1.2, if:

 

9.2.1        the price which Elan must pay for the active ingredient of, or other raw material used to produce, a Product increases by a percentage in excess of the percentage increase in the Index (as compared to the later of the Effective Date or the most recent price adjustment pursuant to this Clause 9.2);

 

9.2.2        additional regulatory obligations are imposed on Elan by law or a Governmental Authority; or

 

12



 

Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.  Such omitted portions, which are marked with brackets [   ] and an asterisk*, h


 
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