Contract

Exhibit 4.10

18 June 2004

Berna Biotech Ltd
Rehhagstrasse 79
CH-3018 Bern
SWITZERLAND


Attention: Kuno Sommer, Chief ExecutiveOfficer

Dear Kuno,

Letter of Amendment to SupplyAgreement

We refer to the Supply Agreement dated 12 November 2001(the Agreement) betweenCSL Limited (CSL)and Berna Biotech Ltd (Berna) for the supply of Product on a worldwidenon-exclusive basis subject to specified Exclusive and Excluded Territories.

As discussed, it is proposed that theAgreement be amended as follows:

1.                          Agreementto Supply

Under clause 1.7, the Agreement pertains tothe supply of Product for Northern Hemisphere influenza vaccine manufacture byBerna. Supply of Product for Berna to manufacture influenza vaccine for theSouthern Hemisphere will be the subject of a separate agreement if the partiesagree to proceed.

2.                          Term andTermination

Under Schedule 1 item 2, the Initial Period ofthe contract is extended by two years to end on 31 December 2009.

3.                          Supplyof Product(s) against Orders

a)                        UnderClause 3.1. Berna is to provide in November each year a five-yearindicative forecast to be discussed at a face to face meeting. At that meetingCSL will confirm whether it expects to be able to supply the forecastedquantity of Product and make adjustments to the indicative non-binding maximumquantities for the five year forecast period.



 

As at the date of thisletter, the quantities outlined in the five-year indicative forecast and up tothe maximum quantities are as follows:

Year

 

Total GM HA

 

25 mcgm doses

2005

 

 

 

 

2006

 

 

 

 

2007

 

 

 

 

2008

 

 

 

 

2009

 

 

 

 

CSL shall use its bestefforts to be able to supply to Berna the quantities outlined in the five-yearindicative forecast and up to the maximum quantities as follows:

Year

 

Total GM HA

 

25 mcgm doses

2005

 

 

 

 

2006

 

 

 

 

2007

 

 

 

 

2008

 

 

 

 

2009

 

 

 

 

Berna will, before 30 June eachcalendar year provide CSL with a written best estimate of its supplyrequirements for the Product for the subsequent year. Within 8 weeks CSL is tonotify Berna whether CSL will be able to supply the forecasted quantity ofProduct for the following season based on expected strains and yields. Bernamay, before 30 November each year, submit to CSL a revised best estimateof its supply requirements.

b)                       Underclause 3.3, each order placed by Berna will be for a minimum quantity of HA foreach calendar year as follows:

Year

 

Total GM HA

 

25 mcgm doses

2005

 

 

 

 

2006

 

 

 

 

2007

 

 

 

 

2008

 

 

 

 

2009

 

 

 

 

CSL confirms and Bernaunderstands and accepts that payment in full is required for the minimumquantity, regardless of whether the minimum quantity is ordered/purchased.

c)                        Underclause 3.4, each of Berna’s orders for Product shall be in writing and shall constitutea binding order upon CSL. Insofar as Berna requires quantities exceeding thosementioned in Berna’s November best estimate CSL shall use reasonableefforts to deliver such quantities.

4.                          Priceand Payment

a)                        Underclause 4.1 the Product(s) will be invoiced at the prices set out inSchedule 2. The price will be based on the number of eggs used to manufacturethe quantity of Product ordered and delivered to Berna. The amount due per eggused will for the year 2005-2009 be as follows:

2005

 

A$        per egg

2006

 

A$        per egg

2007

 

A$        per egg

2008

 

A$        per egg

2009

 

A$        per egg

 

Phone: +61 3 9389 1769

 

CSL Limited ABN 99 051 588 348
45 Poplar Road Parkville Victoria 3052 Australia
June.McKay@csl.com.au

 

Fax: +61 9389 1076

 

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b)                       Under Schedule 2 the 2005 calendar yearprice for a trivalent dose (25 mcgm of each strain) will be based on an amountof A$      peregg used to manufacture the quantity of Product(s) delivered to Berna. Therelationship between price per egg used to manufacture the Product and actualprice paid per 25 mcgm HA of each strain is dependant upon the egg yield. Usingthe five year average yield the price ofA$       per egg used relates to A$       per 25 mcgm trivalent dose. With better than average yields the priceper dose reduces because the processing cost is fixed, as shown in the tablebelow:

Yield_

 

Yield Per Egg
(mcgm/egg)

 

Price / Egg

 

Price per
25mcgm dose

10% above average

 

 

 

 

 

 

5 year average

 

 

 

 

 

 

10% below average

 

 

 

 

 

 

Note: the above yields are indicative only.The actual yield could be greater or less than ±10% from the five-year average.

5.                          ProductRecall

Under clause 19.1 Berna will inform CSLimmediately by telephone or facsimile transmission (immediately confirmed inwriting) in the event of any circumstances giving rise to a possible or actualrecall of Finished Influenza Vaccine containing the Product(s) where therecall is alleged to be due to Product(s). CSL will inform Berna immediately bytelephone or facsimile transmission (immediately confirmed in writing) in theevent of any circumstances giving rise to a possible or actual recall of anybatches of the Product(s) delivered to Berna.

Clauses 19.2, 19.3 and 19.4 will continue infull force and effect.

6.                          AdverseDrug Events

Clause 20.2 and 20.5 and Schedule 4 shall be deleted withoutreplacement. Clause 20.1, 20.3 and 20.4 are changed as follows and will replacethe previous provisions:

a)                        Underclause 20.1 CSL and Berna shall keep each other informed on all reports ofAdverse Drug Events (ADE) coming to either party’s knowledge with regard to theProduct(s) regardless of the origin of such reports. The term Reports shallalso include publications in journals and other media. If Berna receives anyADE report which is both serious and unexpected and alleged to be caused by theProduct(s) Berna will report the matter to the Registration Authority incompliance with the laws and regulations in the Territory.

b)                       Underclause 20.3 Berna will give immediate written notice to CSL of any allegedmanufacturing or other defect in the Products(s) of which Berna becomesaware and of any possible expense, liability, cost, claim or proceeding arisingfrom the alleged defect.

c)                        Underclause 20.4 Berna will not make any admission of liability to any third partywith respect to claims either in the name of Berna or on behalf of CSL withrespect to any adverse experiences alleged to be caused by, and any allegedmanufacturing or other defects in the Product(s) without CSL’s priorwritten consent.

Terms used in this letter shall have the same meaning as defined in theAgreement unless the context requires otherwise. Except as amended by thisletter, the terms of the Agreement remain in full force and effect.

Phone: +61 3 9389 1769

 

CSL Limited ABN 99 051 588 348
45 Poplar Road Parkville Victoria 3052 Australia
June.McKay@csl.com.au

 

Fax: +61 9389 1076

 

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Please confirm Berna’sformal agreement to the above by signing and returning the enclosed copy ofthis letter.

Yours sincerely

/s/ Zita Cunningham

 

 

 

 

 

 

Zita Cunningham

Business Development Director, Pharmaceuticals Group

Accepted and agreed forand on behalf of Berna Biotech Ltd by its duly authorised representative(s):

Illegible, 24 June 2004

 

/s/ Jorg von Manger-Koenig

Place, date

 

Name:

Jörg von Manger-Koenig

 

 

Function:

Executive Vice President Legal,
Regulatory Affairs & IP

 

 

 

 

Illegible, 24.06.04

 

/s/ Dr. Alexandra Fischer-Hauck

Place, date

 

Name:

Dr. Alexandra Fischer-Hauck

 

 

Function:

Director, Global Product Management

 

Phone: +61 3 9389 1769

 

CSL Limited ABN 99 051 588 348
45 Poplar Road Parkville Victoria 3052 Australia


June.McKay@csl.com.au

 

Fax: +61 9389 1076

 

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THIS SUPPLYAGREEMENT is made on the date last signed

BETWEEN:

 

CSL LIMITED ACN 051 588 348
45 Poplar Road, Parkville, Victoria, Australia 3052
Facsimile: (+613) 9389 1434

 

(CSL)

 

 

 

 

 

AND:

 

BERNA BIOTECH LTD
Rehhagstrasse 79, CH-3018 Berne, Switzerland
Facsimile: (+41) 31 980 62 29

 

(BERNA)

WHEREAS:

A.                      CSL isengaged in the manufacture and distribution of human and veterinary pharmaceuticaland diagnostic products.

B.                        BERNA isactive in the manufacturing, distribution and marketing of similar products.

C.                        BERNAwishes to obtain from CSL and CSL wishes to supply to BERNA Bulk InactivatedWhole Virus Influenza Concentrate — Monovalent Pooled Harvest as set out inthis Agreement.

THE PARTIES AGREE

1.                         Agreementto Supply

1.1                    CSL agrees tosupply, and BERNA agrees to purchase, Product(s) on the terms andconditions set out in this Agreement.

1.2                    This Agreementwill oblige CSL to manufacture or (if it is not able to manufacture bydecisions of the authorityconcerned) to deliver the Product(s) as ordered by BERNA and accepted byCSL.

1.3                    Nothing inthis Agreement will restrict BERNA’s ability to deal in bulk influenza vaccine(other than the Product) and Finished Influenza Vaccine formulated with theProduct or other vaccines utilising Virosome technology formulated with theProduct except that BERNA agrees not to sell such vaccines to any third partywhere BERNA knows that same may be used within the Excluded Territory.

1.4                    BERNA will notuse the Product(s) in any way other than as permitted under thisAgreement. In particular, BERNA will use the Product(s) only as a bulkcomponent in the formulation of Finished Influenza Vaccines and other vaccinesutilising Virosome technology.

1.5                    Nothing inthis Agreement will restrict CSL’s ability to deal in bulk influenza vaccineand Finished Influenza Vaccines except that CSL agrees not to sell FinishedInfluenza Vaccines to any third party where CSL knows that same may be usedwithin the Exclusive Territory. BERNA may on or before 30 June 2002request that the Exclusive Territory be expanded and CSL will notify BERNA ofits agreement or otherwise to such expansion on a country by country basis by30 September 2002.

1.6                    Regarding newinfluenza products developed by BERNA, BERNA agrees to consider CSL as adistributing partner for the Excluded Territory.

1.7                    BERNA isinterested to purchase Product(s) for the Southern Hemisphere and CSLagrees to consider BERNA’s request prior to 21 December 2001. If CSLnotifies BERNA that CSL is willing to supply such Product(s), CSL and BERNAwill negotiate in good faith an amendment to this Agreement to provide for thesupply of such Product(s).

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3.                         Supply ofProduct(s) against Orders

3.1                    BERNA will,as soon as practicable after the Commencement Date, provide CSL with a writtenbest estimate of its supply requirements for each of the Product(s) for the2002 calendar year. BERNA will, before 30 June each calendar year, provideCSL with a written best estimate of its supply requirements for each of theProduct(s) for the subsequent calendar year. BERNA may, before 30 November eachyear, submit a revised written best estimate of its supply requirements foreach of the Product(s) for the subsequent calendar year.

3.2                    On or before 28 February, BERNA will place afirm written order with CSL for BERNA’s requirement for Product(s) for theupcoming season. BERNA’s order must be for at least 75% of its 30 June writtenbest estimate provided under clause 3.1.

3.3                    Each orderwill be for a minimum quantity of 100 gm HA per strain for the 2002 calendaryear, 150 gm HA per strain for the 2003 calendar year and for each subsequentcalendar year a scaled up minimum quantity will be agreed between CSL and Bernabased on the agreed European SRID assay.

3.4                    Each orderwill be binding upon CSL unless within 14 days of receipt of an order CSLnotifies BERNA that it does not accept the order in excess of the minimumquantity determined under clause 3.3.

3.5                    Delivery datesfor the Product(s) for the Northern Hemisphere will be based on yield andCSL will use its best endeavours to advise BERNA of estimated delivery dates by15 March. CSL will provide written confirmation of delivery dates by 30 April,which will include any delivery date after 15 July. CSL will use reasonableendeavours to deliver at least 11.5gmHA of each strain by 30 April forregulatory requirements. If BERNA require a commercial delivery prior to 15 June 2002,CSL will only commit to deliver 75% of the quantity ordered by Berna andaccepted by CSL. CSL will use reasonable endeavours to deliver the balance ofthe accepted order by July 15.

3.6                    If CSLdelivers Product(s) in excess of BERNA’s firm order, BERNA must advise CSLin writing of the quantity held in excess as soon as such excess is determined.BERNA will process the excess quantity and store it for potential use in thefollowing Northern Hemisphere season. If the excess quantity is able to be usedin the following seasons, BERNA will pay CSL for the excess quantity at theprice applicable at the time of delivery within 30 days of the officialannouncement of Northern Hemisphere strain selection. If the excess quantity isunable to be used in the following season, BERNA will destroy the excessquantity and notify CSL in writing that the excess quantity has been destroyed.

3.7                    CSL will useits reasonable endeavours to supply the Product(s) in accordance withBERNA’s orders. However, CSL’s liability for any loss or damage which BERNA maysuffer or incur as a result of CSL’s failure to supply the Product(s) inaccordance with accepted BERNA orders will be limited to the value of theaccepted order (or part thereof) which CSL fails to supply. If CSL deliversProduct(s) for the Northern hemisphere to another customer and fails todeliver the accepted Berna order (or part thereof), CSL is liable for any lossor damage Berna may suffer as a result of unfilled Berna customer orders.

3.8                    An indicativetiming program for ordering and price negotiations is set out in Schedule 3.

4.                         Price andPayment

4.1                    The Product(s) willbe invoiced at the prices set out in Schedule 2. For the 2002 calendar year theprice will be based on an amount of A$          peregg used to manufacture that quantity of product delivered to Berna. For the2003 calendar year the price will be based on an amount of          andfor 2004 calendar year the price will be based on an amount of          .The parties will negotiate ingood faith a new price for the 2005 calendar year and the 2006 calendar yearprior to 30 April 2004. The parties will take into account any change inCSL’s manufacturing costs and the general influenza market conditions. If thisagreement is renewed, the

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parties will negotiate ingood faith a new price for the renewal period prior to 30 April of thecalendar year immediately prior to the initial year of the renewal term. Theparties will take into account any change in CSL’s manufacturing costs and thegeneral influenza market conditions.

4.2                    Unlessotherwise agreed in writing all payments will be made under the terms and inthe currency set out in Schedule 2.

4.3                    If theclosing price of the whole market spot rate for the Australian Dollar relativeto the Swiss Franc as reported in The Australian Financial Review deviates bymore than 10% from the closing price for the wholesale market spot ratereported in The Australian Financial Review on the Commencement Date, theparties agree to adjust any amounts due under this Agreement so as to ensure thateach party bears 50% of the exposure created by the deviation. Any furtherdeviation of more than 10% following any adjustment will result in a furtheradjustment on the same terms.

5.                         Packing,Delivery and Risk in Transit

5.1                    CSL will sellthe Product(s) ExWorks (lncoterms 2000), CSL’s Premises. CSL will pack theProduct(s) suitable for delivery to BERNA’s site in Berne, Switzerland.

5.2                    [IntentionallyDeleted]

5.3                    If CSL agreesto arrange delivery on behalf of BERNA (beyond CSL’s obligations under clause5.1) then the cost of freight and insurance arranged by CSL will be to BERNA’saccount, and CSL will be acting as BERNA’s forwarder. BERNA will indemnify andkeep indemnified CSL against all actions, claims, demands, losses, damages,costs (including legal costs on a full indemnity basis) and expenses for whichCSL may become liable which relate directly or indirectly to CSL’s acting asBERNA’s forwarder under this clause.

5.4                    Subject toproduct liability under clause 13, CSL’s obligations under clause 5.1 and thequality control and acceptance procedures, risk in the Product(s) willpass to BERNA upon ExWorks delivery. Property and ownership of the Product(s) willpass to BERNA upon payment.

6.                         QualityControl

6.1                    CSL willsupply Product(s) free of defects in materials and manufacture, and incompliance with the Specification and any Conditions of Registration (includingprotocols to EU-regulations) set by the Registration Authority of which BERNAhas given CSL reasonable prior written notice.

6.2                    CSL and BERNAwill enter into a GMP Agreement, which is to be reviewed annually on or before30 November, that is to be consistent with terms of this Agreement.

6.3                    CSL will keepproper records and reference samples of all of its manufacturing and qualitycontrol activities performed under this Agreement. CSL will provide, onrequest, to Berna a copy of CSL’s current TGA certificate. BERNA may audit suchrecords and the production facilites at reasonable intervals, on reasonablenotice during normal business hours.

6.4                    CSL willnotify BERNA of any special storage requirements for the Product(s).

6.5                    BERNA willstore the Product(s) in suitable storage facilities having regard to boththe Specification and Conditions of Registration and in a manner which ensuresproper rotation of stock.

6.6                    BERNA willtest samples of delivered Product(s) and if it believes a particularProduct(s) (hereinafter referred to as “the Notified Product”) does notcomply with clause 6.1, it will notify CSL advising the batch number. CSL will examineand test from that batch a sample retained by it (hereinafter referred to as “the Batch Sample”). If CSL finds theBatch Sample does not comply with clause 6.1 then CSL will if practicablereplace the Notified Product in due time and after discussion with BERNA.

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6.7                    If CSL findsthe Batch Sample does comply with clause 6.1 and BERNA, based on its ownresults, does not accept CSL’s findings, then a mutually agreed independenttesting agency will make a final decision with regard to the release specificationof the Notified Product, and that finding will be conclusive for the two parties. If it supports CSL findingsit is evidence for all purposes that the Notified Product complied with inclause 6.1 when loaded for delivery at CSL’s premises. CSL will not be liableto replace or allow a credit in respect of the Notified Product. The allegedfailure of the Notified Product to comply with clause 6.1 will be deemed tohave arisen or been caused by reason of an act or default of a person (notbeing CSL or an employee or agent of CSL) or a cause independent of humancontrol occurring after the Notified Product was loaded for delivery at CSL’spremises. If the releasing authority’s findings do not support CSL’s findingsthe Product(s) CSL will if practicable replace the Notified Product in duetime and after discussion with BERNA. The cost of the independent testingagency will be shared equally by CSL and BERNA regardless of the outcome.

7.                         BERNA’sand CSL’s Duties and Obligations

7.1                    BERNA will:

(a)                    only distributeand sell Finished Influenza Vaccine and other vaccines utilising Virosometechnology containing the Product(s) as agreed under this Agreement

(b)                   comply with alllaws, ordinances, regulations, rules and administrative directionsapplicable to or governing or controlling the importation of the Product(s) into,and the sale and use of the Product(s) in, the Territory

(c)                    notify CSL ofany reason BERNA has to believe that a particular Product(s) does notcomply with clause 6.1 as soon as possible and preferably within fourteen daysof that reason coming to the attention of BERNA. The notification will identifythe particular Product’s batch number. BERNA will also notify CSL of anyAdverse Drug Events under clause 20.

7.2                    BERNA and CSLwill ensure that their respective employees, agents and dealers are acquaintedwith the obligations imposed by this Agreement to the extent reasonablynecessary to ensure compliance with the Agreement.

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8.                         Promotionand Marketing

8.1                    BERNA willhave the absolute unilateral right to determine its promotion and marketingactivities, and the prices at which it will sell the Finished Influenza Vaccinecontaining the Product(s) and to determine payment arrangements withpurchasers of the same. CSL does not desire to participate and will notparticipate in any price determinations.

9.                         Provisionof Technical Information

9.1                    CSL, at itsexpense, and as soon as practicable after the Commencement Date, will makeavailable to BERNA all technical information relating to the Product(s) whichCSL considers relevant to the reasonable needs of BERNA under this Agreementand to the extent CSL has the right to divulge the information. Nothing in thisAgreement other than the required responses to the Registration Authority willoblige CSL to make available to BERNA any information, technical or otherwise,which is in any way referable to the manufacture, formulation, production orprocessing of the Product(s).

9.2                    BERNA mayuse any technical information made available to it pursuant to this clause butonly for the proper discharge of its obligations. BERNA will not use any of thetechnical information made available to it for any purpose after this Agreementends. For Confidential Material see clause 12.

10.                  [IntentionallyDeleted]

11.                  RegistrationRequirements

11.1              BERNA will effect,in its own name and at its expense, any necessary registrations of the Product(s) inthe Territory. BERNA will provide CSL with all data and information and copiesof all documentation to enable CSL to comply with its obligations under thisAgreement.

11.2              CSL will assistBERNA with dossier preparation, at BERNA’s cost. CSL and BERNA will consult andagree on all dossier requirements (updates) and CSL’s costs by 30 November eachyear for the following calendar year.

12.                  Confidentiality

12.1              Each party will:

(a)                    keep allConfidential Material disclosed to it by the other party confidential;

(b)                   not permit theother party’s Confidential Material to be disclosed other than in confidence toits employees to the extent strictly necessary for the purposes of thisAgreement;

(c)                    use the otherparty’s Confidential Material only for the purpose of this Agreement and not touse for any commercial purpose other than under a further agreement with theother party;

(d)                   not copy orreduce to writing the other party’s Confidential Material except as reasonablynecessary for the purposes of this Agreement. Copies or reductions to writingof Confidential Material of the other party shall be owned by that party;

(e)                    maintain theother party’s Confidential Material in a way which provides adequate protectionfrom unauthorised disclosure, copying or use;

(f)                      indemnifyand keep indemnified the other party against all actions, claims, demands,losses, damages, costs and expenses for which the other party may become liablewhich arise as a result of an unauthorised disclosure of the other party’sConfidential Material; and

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(g)                   return promptlyto the other party all documentsand materials (and all copies thereof) containing the other party’sConfidential Material at the end of this Agreement.

12.2              “ConfidentialMaterial” means all proprietary information disclosed by, or on behalf of, oneparty to the other party relating to this Agreement and includes:

(a)                    informationdisclosed in writing, verbally or by any other means,

(b)                   informationdisclosed before, after or on the Commencement Date; and

(c)                    informationrelating to the other party’s operations, processes, plans, intentions,production information, know-how, data, formulae, expertise, methodology,drawings, specifications, design rights, trade secrets, market opportunitiesand business affairs, and any new and novel combinations thereof.

but excludes information which the receiving partyproves:

(d)                   is in or hascome into the public domain in any way without it breaching this Agreement;

(e)                    it hasdeveloped independently as a result of its operations and activities;

(f)                      it hasobtained or has available from a source other than the disclosing party withoutbreach of any obligation of confidentiality or non-use;

(g)                   it knew priorto being disclosed by the disclosing party; or

(h)                   it hasdisclosed with the prior written approval of the disclosing party.

12.3              Either party maydisclose the other party’s Confidential Material in confidence to theRegistration Authority to the extent required to comply with the law and itsobligations under this Agreement.

13.                  ProductLiability

13.1              CSL will indemnifyand keep indemnified BERNA against all actions, claims, demands, losses,damages, costs (including legal costs on a full indemnity basis) and expensesfor which BERNA may become liable which relate directly or indirectly to theProducts, their uses or effects but only to the extent arising from a breach ofthis Agreement (including failure of Product(s) to comply with theSpecifications) by, or the negligence or wilful default of, CSL.

13.2              BERNA will indemnifyand keep indemnified CSL against all actions, claims, demands, losses, damages,costs (including legal costs on a full indemnity basis) and expenses for whichCSL may become liable which relate directly or indirectly to BERNA’s alteredProduct in any form, whether bulk, finished or otherwise, their uses or effectsexcept to the extent arising from any breach of this Agreement by, or thenegligence or wilful default of, CSL.

14.                  Term andTermination

14.1              This Agreement willbegin on the Commencement Date and remain in effect during the Initial Period.It will thereafter be renewed for successive two year periods until terminated.

14.2              Either party mayterminate this Agreement on 12 months notice to end at the end of the InitialPeriod or any successive two year period thereafter.

14.3              Theparty not affected may terminate this Agreement by giving to the other partywritten notice to terminate on the date specified in the notice if:

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(a)                    a party failsto rectify any breach of its obligations within 30 days of receiving a writtennotice requiring it to do so;

(b)                   if a partybecomes insolvent, is adjudged bankrupt, applies for judicial or extra-judicialsettlement with its creditors, makes an assignment for the benefit of itscreditors, voluntarily files for bankruptcy or has a receiver or trustee (orthe like) in bankruptcy appointed over its business, property or assets, orbecomes the subject of liquidation or dissolution (except for reconstructionpurposes such as mergers, etc) or involuntary bankruptcy proceedings orotherwise discontinues business;

(c)                    any otherright of termination in favour of the first party arises under this Agreement;or

(d)                   a change ineffective control of the other party.

14.4              If an importantparameter changes so materially that the continuation of this agreement wouldlead to a material adverse financial effect for a party, that party may bywritten notice request a negotiation in good faith to amend the terms of thisAgreement to address the change in that parameter. If the parties are unable toagree on an appropriate amendment within three months of the date of thenotice, either party may terminate this Agreement by immediate written notice.Such termination will not affect firm commitments made in connection with thesupply of Product(s) for the upcoming Northern Hemisphere influenzaseason.

14.5              Termination will notaffect any other rights or obligations which may have accrued prior totermination.

14.6              At the end of thisAgreement BERNA will promptly forward to CSL, at BERNA’s expense, all technicalinformation relating to this Agreement it received from CSL BERNA will not keepany copies.

15.                  General

15.1              No waiver of anyprovision of this Agreement will be of any force or effect unless confirmed inwriting, signed by the parties. Then such waiver will be effective only to theextent for which it is made.

15.2              The invalidity orunenforceability of any provision of this Agreement will not affect the validityand enforceability of all other provisions which are self-sustaining andcapable of separate enforcement.

15.3              This Agreementconstitutes the entire agreement and understanding between the parties withrespect to its subject matter. It replaces all previous agreements between, orundertakings by either of, the parties with respect to its subject matter.

15.4              This Agreement canonly be changed by written agreement of the parties.

15.5              Unless expresslyprovided elsewhere in this Agreement, the relationship between the parties isthat of independent parties and will not be deemed to be that ofprincipal/agent, joint venture, partnership or otherwise.

15.6              The laws ofVictoria, Australia will govern this Agreement.

15.7              Clauses 11,12,13,14.5 and 17.1 will continue to apply after this Agreement ends.

15.8              Neither party willbe liable for any failure or delay in the performance of its obligations underthis Agreement to the extent that such failure or delay arises from anycircumstance beyond its control including any Acts of Nature, strikes,lock-outs, labour disputes or in the event of an influenza pandemic in theExcluded Territory. Where such failure or delay continues for a continuousperiod exceeding six months, the party not experiencing such failure or delaymay terminate this Agreement

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without penalty by written notice. The partiesacknowledge that manufacturing and formulation of the Product(s) andFinished Influenza Vaccine is an extremely time sensitive business andtherefore agree to notify each other as early as possible of any failure ordelay under this clause 15.8.

15.9              Each party will bearits own legal costs and expenses of and incidental to the preparation of thisAgreement.

15.10        This Agreement will bindand enure for the benefit of the parties and their respective successors intitle. Neither party may assign any of its rights and obligations without theprior written consent of the other party.

16.                  Notices

16.1              Any written noticerequired under this Agreement must meet all of the following

(a)                    be given bypre-paid post, personal delivery or facsimile transmission;

(b)                   be sent to thecontact address or facsimile number given above (or any other point previouslyadvised in writing by the recipient), and

(c)                    be marked tothe attention of a signatory to this Agreement (or any other person previouslyadvised in writing by the recipient).

16.2              No written notice isto be effective until received, or deemed to be received by the other party asfollows:

(a)                    in the case ofpersonal delivery, upon delivery;

(b)                   in the case ofa letter, on the fifth business day after posting; and

(c)                    in the case ofa facsimile transmission, on the business day on which it is despatched, or, ifdespatched on a non-business day, or after 5 pm on a business day then on the nextbusiness day after day on which it is despatched. A record from the despatchingfacsimile machine detailing the time and date of the transmission will beevidence of transmission, unless proved to the contrary.

Times and business days will be determined accordingto the place of receipt.

17.                  Arbitration

17.1              All disputes arisingunder this Agreement will be finally settled under the Rules ofConciliation and Arbitration of the International Chamber of Commerce inZurich, where CSL initiates the action, or in Melbourne, where BERNA initiatesthe action, by one or more arbitrators appointed in accordance with thoseRules. All arbitrations will be conducted in the English language.

18.                  Benefit ofIndemnities

18.1              For the avoidance ofdoubt, it is agreed that where a party agrees to indemnify the other, theindemnified party will be or be deemed to be acting as agent for and on behalfof and for the benefit of all persons who are or might be its directors,officers, employees, consultants or agents from time to time and all suchpersons will to this extent be or be deemed to be parties to this Agreement.

19.                  Product Recall

19.1              BERNA will informCSL immediately by telephone or facsimile transmission (immediately confirmedin writing) in the event of any circumstances giving rise to a possible oractual recall of any Finished Influenza Vaccine containing the Product(s). CSLwill inform BERNA immediately by telephone or

8



 

facsimile transmission (immediately confirmed inwriting) in the event of any circumstances giving rise to a possible or actualrecall of any batches of the Product(s) delivered to BERNA.

19.2              CSL has the right(irrespective of any power granted by law to the Registration Authority orother authority in the Territory) on the grounds of public health and safety torequire BERNA to evaluate and in case to discontinue sale of and recover someor all batches of Finished Influenza Vaccine containing the Product(s) specifiedby CSL. If BERNA does not so discontinue sale, any sales made after the date ofCSL’s request under this clause 19.2 will be made solely at BERNA’s own riskand the indemnity in clause 13.1 will not apply.

19.3              Where a productrecall has been initiated whether by the Registration Authority or otherauthority in the Territory or by BERNA or CSL under clause 19.2 BERNA will inform all purchasers of theProduct(s) so affected and shall require them to deliver or make availablefor collection all such stocks of Finished Influenza Vaccine containing thedefective Product(s) in their possession. BERNA will ensure that all suchstocks of Finished Influenza Vaccine containing the defective Product(s) arecollected and stored in secure conditions on premises controlled by BERNA.

19.4              Costs of any actiontaken under this clause 19 will be borne by BERNA unless the costs are causedby the breach of this Agreement, (including failure of Product(s) tocomply with the Specifications) by, or negligence or wilful default of, CSL, inwhich case CSL will indemnify BERNA against any and all actions, claims,demands, losses, damages, costs and expenses for which BERNA may become liablewhich arise from such breach, negligence or wilful default.

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20.                  Adverse DrugEvents

20.1              If BERNA receivesany Adverse Drag Event (ADE) report which is both serious and unexpected andalleged to be caused by Finished Influenza Vaccine containing the Product(s) BERNAwill report the matter according to Schedule 4 to the Registration Authority incompliance with the laws and regulations of the Territory, and inform CSLwithout delay by telephone or facsimile transmission (immediately confirmed inwriting). CSL will acknowledge receipt within 24 hours by facsimiletransmission.

20.2              BERNA will report toCSL by telephone or facsimile transmission (immediately confirmed in writing)any other adverse experience occurring in the Territory and alleged to becaused by Finished Influenza Vaccine containing the Product(s) every threemonths.

20.3              BERNA will giveimmediate written notice to CSL of any alleged manufacturing or other defect inthe Product(s) or Finished Influenza Vaccine containing the Product(s) ofwhich BERNA becomes aware and of any possible expense, liability, cost, claimor proceedings arising from the alleged defect.

20.4              With respect to anyadverse experiences alleged to be caused by, and any alleged manufacturing orother defects in, the Product (s)or Finished Influenza Vaccine containing same BERNA will not make any admissionof liability to any third party with respect to claims either in the name ofBERNA or on behalf of CSL without CSL’s prior written consent.

20.5              For the purpose ofthis clause 20, “serious” and “unexpected” will have the meaning ascribed to itat the relevant time by the Registration Authority or as otherwise notified byCSL from time to time.

21.                  Definitions andInterpretation

21.1              In this Agreement:

(a)                    Batch Sample is defined in clause 6;

(b)                   Commencement Date means 1 November 2001;

(c)                    Confidential Material is defined in clause 12;

(d)                   CSL’s Premises means CSL’s premises at 45 Poplar Road, Parkville,Victoria, Australia, 3052 or suet other address notified to BERNA in writing byCSL;

(e)                    Exclusive Territory means the territory set out in Item 1A ofSchedule 1;

(f)                      Excluded Territory means the territory set out in Item IBof Schedule 1;

(g)                   Finished Influenza Vaccine means product that is intended for theprevention of influenza only and is formulated, filled in final container andpacked;

(h)                   GMP Agreement means an agreement which specifies theAustralian Code of Good Manufacturing responsibilities relating to themanufacture of the Product(s);

(i)                       ha means haemaglutinin

(i)                       Initial Period means the period set out in Item 2 ofSchedule 1;

(i)                       Notified Product is definedin clause 6;

(j)                       SRID means the single radial immunodifusion;

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(k)                    Territory means theterritory set out in Item IA of Schedule 1;

(l)                       Product means theproduct set out in Schedule 2;

(m)                 Registration Authority means SwissFederal Office of Public Health or any other body responsible for theregistration of the Product(s) in the Territory from time to time;

(n)                   Specification means the Product Specification set outin Schedule 2; and

(o)                   Virosome means virus-like particles consisting ofartificial bilayer liposomes with integrated viral surface antigens imitating avirus as developed and used by BERNA;

21.2.           In this Agreement:

(a)                    Words denotingthe singular number include the plural number and vice versa;

(b)                   Words denotingany gender include all genders;

(c)                    References topersons include bodies corporate and vice versa;

(d)                   Words definedin another part of this Agreement will have the meaning given in that part;

(e)                    References toRecitals, clauses, sub-clauses, Schedules and Annexures are references toRecitals, clauses, sub-clauses, Schedules and Annexures of or to this Agreement;

(f)                      Referencesto the parties include references to respective directors, officers, employeesand agents of the parties; and

(g)                   Headings areinserted for convenience only and will not affect interpretation.

22.                  Enclosures

Schedule 1:

Territory and Duration

Schedule 2:

Product(s), Prices and Payment Terms

Schedule 3:

Timings

Schedule 4:

Adverse Drug Event (ADE) reporting Guidelines

 

11



 

SIGNED as an Agreement by the parties

Signed for and on behalf of

)

 

 

CSL Limited ACN 051 588 348

)

/s/ Colin Armit

12/11/01

by its duly authorised

)

Colin Armit

(date)

representatives

)

President Pharmaceuticals

 

 

)

 

 

 

)

/s/ Peter Turvey

11/11/01

 

)

Peter Turvey

(date)

 

)

Company Secretary

 

 

 

 

 

 

 

 

 

 

 

 

 

 

)

/s/ Patrik Richard

02/11/2001

Signed for and on behalf of

)

Patrik Richard

(date)

Berna Biotech Ltd

 

Secretary General

 

by its duly authorised

 

 

 

representatives

 

/s/ Robert Mischler

02/11/2001

 

 

Robert Mischler

(date)

 

 

Head of Production

 

 

12



 

SCHEDULE 1
to the Supply Agreement between CSL and BERNA

Territory and Duration

1:

Territory:

Worldwide non-exclusive subject to 1A and 1B below.

1A:

Exclusive Territory:

Switzerland, Italy, Spain and Portugal.

1B:

Excluded Territory:

Australia and New Zealand.

2.

Duration:

The Initial Period commencing from the Commencement Date and ending on 31 December 2006.

 

 

13



 

SCHEDULE 2
to the Supply Agreement between CSL and BERNA

Product(s), Prices and Payment Terms

Product(s):

Bulk Inactivated Whole Virus Influenza Concentrate — Monovalent Pooled Harvest.

Price:

The 2002 calendar year price for a trivalent dose (25mcgm of each strain) will be based on an amount of

per egg used to manufacture the quantity of Product(s) delivered to BERNA. The relationship between price per egg used to manufacture the product and actual price paid per 25mcgm HA of each strain is dependant upon the egg yield. Using the average yield for the period l990-2000 the price of          per egg used relates to           per 25mcgm trivalent dose. With better than average yields the price per dose reduces because the processing cost price is fixed, as shown in the table below.

 

Yield

 

Yield Per Egg
(mcgm/egg)

 

Price/Egg

 

Price Per
25mcgm Dose

10% above average

 

 

 

 

 

 

10 Year Average

 

 

 

 

 

 

10% below average

 

 

 

 

 

 

 

Note:

· the yield is indicative only, the actualyield could be greater or lower than ± 10%.

CSL will notify BERNA ofindicative total cost of total order after one month of processing, ieindicative yields will be communicated but accurate costs (total numbers ofeggs used) will not be finalised until completion of the total order. CSL willnotify BERNA with each delivery the total number of inoculated eggs used.

The quantity ofProduct(s) delivered will be determined pursuant to the accepted SRIDassay method using the agreed SRID standard and the volume measured by CSL andBERNA. Any difference of 10% or less between the CSL and BERNA test will resultin a sharing of the variance in terms of price on a 50:50 basis. If there is adifference of more than 10% discrepancy between the CSL and BERNA test, CSL andBERNA will discuss in good faith a resolution. If CSL and BERNA are unable toresolve the discrepancy, then an independent testing agency tests the material.The accepted result will be the average of the two closest results. The cost ofthe independent testing agency will be shared equally by CSL and BERNAregardless of the outcome.

Payment Terms:

 

If not otherwise specified, payment is due 60 days from date of invoice. Prices in Australian Dollars Ex Works, Parkville, Victoria 3052 (Incoterms 2000).

Product Specification:

 

General Specifications according to Specifications of European Pharmacopoeia already delivered to CSL.

 

Any change of the EuPharmmonography on influenza vaccines and Product testing requirements shall be sentby BERNA to CSL or CSL to BERNA as soon as possible.

The Specifications for thestrains for the coming season shall be fixed according to the recommendationsof WHO and EU respectively and set out in BERNA’s order to CSL.

 

14



 

SCHEDULE 3
to the Supply Agreement between CSL and BERNA

Timing ofForecasts, Orders, etc

 

Written best estimate from BERNA for following calendar year.

 

30 June

 

 

 

Update of written best estimate from BERNA for following calendar year.

 

30 November

 

 

 

Written notification from BERNA of packaging requirements.

 

30 November

 

 

 

GMP Agreement review and agreement regarding dossier preparation/updates.

 

30 November

 

 

 

Notification of Price Increase by CSL.

 

31 January

 

 

 

Firm order by BERNA.

 

28 February

 

 

 

Notification of Indicative Delivery Date by CSL.

 

15 March

 

 

 

Confirmation of Delivery Dates by CSL.

 

30 April

 

15



 

SCHEDULE 4
to the Supply Agreement between CSL and BERNA

Adverse Drug Event(ADE) Reporting Guidelines
(Clause 20)

1.                          Principle:The Adverse Drug Event (hereinafter ADE) reporting system shall correspondbasically to the European Union Directive (EU) 93/39 and the correspondingregulations of each country of the Territories brought to knowledge of theBERNA. The ADE shall preferably be forwarded using the format of the COMS-formulary.

2.                          CSL andthe BERNA shall keep one another informed on all reports of ADEs coming toeither party’s knowledge with regard to the Product(s), regardless of theorigin of such reports. The term “Reports” shall also include publications injournals and other media.

3.                          Reportson such ADEs which according to the informing party’s careful professionalevaluation may negatively affect the benefit-risk-ratio of the Product or mayhave consequences regarding the Product’s Information (eg. labelling, datasheets, package inserts) or may require immediate safety measures or regulatoryauthorities (such as special information/warnings to the medical profession,patients, authorities or withdrawal of the Product) shall be forwarded to theother party without delay after having become known.

4.                          The sameimmediate forwarding, without delay shall apply in cases of reports on ADEsbeing both serious and unexpected (ie. hitherto not specified in the Product’sInformation).

5.                          Theinforming party is invited to give both the primary reporter’s and its ownprofessional evaluation of such reports, in particular with regard to suspectedcausality, with reasoning, either together with such information or at a laterdate.

Categories for determining relationship of ADE to the Product:

·  Certain

·  Probable

·  Possible

·  Unlikely

·  Unrelated

·  Insufficient Evidence

6.                          Theaforementioned Information shall be addressed to

in case of CSL:   CSL LIMITED ACN051 588 348

Attention:

Head Medical Department

45 Poplar Road, Parkville, Victoria, Australia 3052

Telephone:

+61 3 9389 1911

Facsimile:

+61 3 9389 1434

 

 

BERNA BIOTECH LTD

Attention:

Head Medical Department

Rehhagstrasse 79, CH-3018 Berne, Switzerland

Telephone:

+41 31 980 67 37

Facsimile:

+41 31 980 67 75

or to such other address as may thereafter be providedby either party.

7.                          Reportsshall be established by BERNA and delivered according to clause 20 andmeetings, if necessary, shall be held at mutually convenient times and places,for the purpose of discussing ADE issues.

8.                          All reportsto be provided hereunder shall be in English, using the MeDRA adverse reactionterminology.

 

16