Visar inlägg med etikett glaxo sekretess. Visa alla inlägg
Visar inlägg med etikett glaxo sekretess. Visa alla inlägg

2009-12-15

Dokument: Det Mindre Hemliga Vaccinavtalet

(Nu med fungerande länk till dokumentet..:)....)
Garantiavtalet som Sverige ingick 2007 med GlaxoSmithKline gällande ett pandemivaccin finns här att läsa och/eller ladda ner, dvs den version av avtalet som Kammarrätten har beslutat ej längre är belagt med sekretess.
Tyvärr så är det ändå fortfarande många sidor som är hemliga, t.ex. de om "Development Plan" och "Business Continuity Plan".
Jämför gärna med denna version som innan domen var det som var offentligt, så kommer du se vad man ansåg vara för hemligt/känsligt för oss vanliga småfolk att se och veta...

Direkt finner jag saker som iaf jag finner högst anmärkningsvärda för ett avtal i denna dignitet:
"GlaxoSmithKline A.B.
Råsundavägen 12,
Box 516, SE - 169 29 Solna,
Sweden ("GSKAB")
Ovan är två extrema nybörjarmisstag begångna, då dels bolagsformen skrivits fel (A.B.) samt att organisationsnumret för detta bolag helt saknas. Bara detta faktum kan ogiltigförklara avtal, då det inte framgår tydligt vilken avtalsparten är. GSK's organisationsnummer är 556236-6343. Deras totala omsätttning 2008 var 1 063 miljoner, mao så inbringar detta avtal mer än hela deras årsomsättning...
GlaxoSmithKline Biologicals SA
Rue de l'Institut 89B
-1330 RixensartBelgium ("GSK Bio")
(GSK AB and GSK Bio together "GSK")
and
National Board of Health and Welfare Organisation
registration number 202100-055
106-30 Stockholm
Sweden ("NBHW")
Vi har inte kommit längre än till mellan vilka avtalsparterna är, och redan är det tredje stora missen uppenbar. Sista siffran i organisationsnumret är inte med, vilket också gör avtalet väldigt osäkert. Vi kan faktiskt säga att vi med 100% säkerhet inte kan garantera ens vilka som är avtalsparter, en otroligt viktig grund gällande avtal. Försök själv att teckna t.ex ett hyresavtal eller lån helt utan ditt personnummer, eller med den sista siffran borta. Det går inte, och ska inte heller gå... Är detta kanske ett skämtavtal? Det verkar i alla fall vara skojande clowner som skrivit det hittills...
Stockholm County Council Organisation
registration number 232100-0016
Box 6401
113 82 Stockholm
Sweden"
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Några andra snabba betraktelser.....:
En punkt säger att "minimum order quantity" är 50% av den pandemiska volymen, som enligt avtalet är 18 miljoner doser. Mao så måste inte staten, ifall avtalet ens är giltigt, köpa mer än 9 miljoner doser...
Priset är 7 € per dos, där adjuvansen står för hela 6 €!!
Växelkursen fixerades vid avtalets tecknande till 9.20 SKR / 1 €.
Totalt så kan GSK casha in som mest 1 159 200 000:-, vilket då är nästan 100 miljoner mer än hela deras omsättning i Sverige för 2008!!
Staten kan, enligt avtalet, undvika att spendera nästan 580 miljoner på att köpa 9 miljoner doser som högst troligt inte ens kommer att användas...
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Det nedan som är med fet text är lite av det som man tidigare ville hålla från allas vår kännedom:
"GSK proposes to manufacture and supply to SCC the Group's Pandemic Vaccine in the event of a human influenza pandemic. Such vaccine will comprise separate adjuvant and antigen components, with the antigen component being based on the anticipated pandemic-specific H5N1 influenza virus strain or such other strain as is technically and commercially feasible, and which is identified by WHO at the time of the Production Switch or otherwise recommended by WHO and EMEA. GSK intends, subject to the completion of further development work, to develop a single vial presentation of the Pandemic Vaccine. lf this development is successful, GSK intends to amend the Specification accordingly and to obtain appropriate Reguiatory Authorisation." (Sida 4)
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"GSKs manufacturing capacity of the Pandemic Vaccine is dependent on a number of factors such as the exact strain, the production yieid of the antigen for such strain and the amount of antigen content required in the Pandemic Vaccine. Production and release of the bulk antigen material and filling of the Pandemic Vaccine may commence only after receipt by GSK Bio of the relevant antigen seed and associated reagents from the WHO reference laboratory, which is beyond GSK's control." (Sida 4)

"AdditionaI Production Line" means the second production line expected to be implemented at the Pandemic Antigen Facility in order to increase production capacity of the Pandemic Antigen Component. (Sida 5)

"All Reasonable Endeavours" means using in respect of the stated activity or objective, the resources employed by GSK in its vaccines business to take such action which, having regard to all the facts and circumstances at the time of performance (i) is feasible and (ii) does not cause GSK or its Affiliates to incur, directly or indirectly, unreasonable financial burdens and (iii) does not materially impact manufacturing activities relating to vaccines that the EMEA, WHO or other international organisation has identified as essential.
ln any event, where the costs of an action would result in GSK supplying Pandemic Vaccine at a loss, such costs shall be deemed to impose unreasonable financial burdens on GSK for these purposes. For the avoidance of doubt, if and to the extent that GSK does not take an action to fulfil its obligations under this Agreernent because it has decided that producing and delivering Pandemic Vaccines to other parties is more profitable than fulfilling its obligations under this Agreement, GSK shall not be considered to be using All Reasonable Endeavours.
(Sida 5 & 6)

"Allocated Percentage" means the percentage set out in Exhibit C Specific
Terms.
(Sidan 6)

"Allocated Production Volume" means the number of Doses of Pandemic Antigen Component corresponding to the Allocated Percentage of the actual weekly production volume of Pandemic Antigen Component at the Pandemic Facilities (excluding any failed batches and retained samples) and an equal number of Doses of Adjuvant Component. (Sida 6)

"Cross Reactive Immunity" means an immune response against either (a) an H5N1 virus strain of a different clade than the one used in the Pandemic Antigen Component previously suppbed under this Agreement or (b) a non-H5N1 virus strain as demonstrated by the induction of seroconversion rates (defined as 4 times increase in neutralizing antibody titers) in at least 60% of adult subjects previously vaccinated under the relevant group of subjects in study D-Pan 007 with 2 doses of Pandemic Vaccine previously supplied under this Agreement. (Sida 7)

"Delivery" and "Deliver" means completion by GSK or an Affiliate of all activities of the seller under the definition of Ex Works delivery in 1NCOTERMS2 000, at the Place of Delivery. (Sida 7)

"Downgrade Declaration" means a declaration by WHO that Phase 4 (or above) is downgraded to Phase 3 (or less) with respect to an influenza pandemic in accordance with the phases published by WHO as set out in Exhibit F —WHO Pandemic Phases. (Sida 7)

"Early Switch" means a Production Switch prior to Pandemic Deciaration in accordance with the procedure set out in Exhibit H — Switch Process. (Sida 7)

"End of Pandemic Declaration" means the end of an influenza pandemic and start of the influenza inter-pandemic period as identified by a deciaration by WHO that Phase 6 is downgraded to Phase 5 (or less) with respect to an influenza pandemic in accordance with the phases published by WHO as set out in Exhibit F —WHO Pandemic Phases. (Sida 7)

"End of Production Event" means an End of Pandemic Declaration or a Downgrade Declaration, as the context admits. (Sida 8)

"European Customers" means those countries in Europe and Israel (or their representatives) which, at the time in question, have a contract with GSK or any of its Affiliates for the supply of Pandernic Vaccine for which the Pandemic Antigen Component will be manufactured at the Pandemic Antigen Facility, including the Authorities during the Term. (Sida 8)

"Filling or Packaging Facilities" rneans the filling or packaging facilities, as the case may be, at Wavre and/or Rixensart in Belgium owned and operated by GSK Bio or an Affiliate or such other facilities as GSK may designate from time to time, including sub-corttractors meeting the same GMP standards as applicable within GSK. (Sidan 8)
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"Minimum Order Quantity" means fifty per cent 50% of the Pandemic Volume. (Sidan 9)

"New Recommended Virus Strain" shall have the meaning set out in section 3.7. (Sidan 9)
.....och mycket, mycket, mycket mer.
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Tidsbrist hindrar mig just nu att plita ner mer om detta, men ni kan alla själva kika på dokumenten som sagt.
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Återkom gärna med vad ni kommer fram till själva...