natgillin/translations-raw huggingface dataset:
Since the objective of this Regulation, namely establishment of the IMI2 Joint Undertaking in order to strengthen industrial research and innovation across the Union cannot be sufficiently achieved by the Member States but can rather, by reason of avoiding duplication, retaining critical mass and ensuring that public financing is used in an optimal way, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Člen 1
In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
Ustanovitev
HAS ADOPTED THIS REGULATION:
Skupno podjetje IMI2 nadomešča Skupno podjetje IMI, ustanovljeno z Uredbo (ES) št. 73/2008, in je njegov naslednik.
Establishment
Skupno podjetje IMI2 je pravna oseba.
For the implementation of the Joint Technology Initiative on Innovative Medicines, a joint undertaking within the meaning of Article 187 of the Treaty on the Functioning of the European Union (‘IMI2 Joint Undertaking’), is established for a period until 31 December 2024.
V vseh državah članicah uživa najširšo pravno in poslovno sposobnost, ki jo pravnim osebam priznava zakonodaja navedenih držav.
In order to take into account the duration of Horizon 2020, calls for proposals by the IMI2 Joint Undertaking shall be launched at the latest by 31 December 2020.
Zlasti lahko pridobiva premičnine in nepremičnine ter z njimi razpolaga in nastopa kot stranka v sodnem postopku.
In duly justified cases calls for proposals may be launched by 31 December 2021.
Sedež Skupnega podjetja IMI2 je v Bruslju v Belgiji.
The IMI2 Joint Undertaking shall replace and succeed the IMI Joint Undertaking, established by Regulation (EC) No 73/2008.
Statut Skupnega podjetja IMI2 je določen v Prilogi.
The IMI2 Joint Undertaking shall be a body entrusted with the implementation of a public-private partnership referred to in Article 209 of Regulation (EU, Euratom) No 966/2012.
Člen 2
The IMI2 Joint Undertaking shall have legal personality.
Cilji
In each of the Member States, it shall have the most extensive legal capacity accorded to legal persons under the laws of those Member States.
Skupno podjetje IMI2 ima naslednje cilje:
It may, in particular, acquire or dispose of movable and immovable property and may be party to legal proceedings.
podpirati razvoj in izvajati predkonkurenčne dejavnosti na področju raziskav in inovacij, ki so strateškega pomena za konkurenčnost Unije in njen vodilni položaj v industriji, v skladu s členom 25 Uredbe (EU) št. 1291/2013, ali obravnavati specifične družbene izzive, zlasti kot so opisani v delih II in III Sklepa 2013/743/EU, ter predvsem izziv izboljšanja zdravja in blaginje evropskih državljanov;
The seat of the IMI2 Joint Undertaking shall be located in Brussels, Belgium.
prispevati k ciljem skupne tehnološke pobude za inovativna zdravila in zlasti:
The Statutes of the IMI2 Joint Undertaking are set out in the Annex.
povečati uspešnost kliničnih preskušanj prednostnih zdravil, ki jih je določila Svetovna zdravstvena organizacija;
Article 2
po potrebi skrajšati čas za pridobitev kliničnega dokaza zasnove pri razvoju zdravil, na primer za raka ter imunološke, respiratorne, nevrološke in nevrodegenerativne bolezni;
Objectives
razviti nove načine zdravljenja bolezni, pri katerih obstaja veliko nezadovoljenih potreb (npr. Alzheimerjeva bolezen), in pri katerih so tržne spodbude omejene (npr. odpornost proti protimikrobnim zdravilom);
The IMI2 Joint Undertaking shall have the following objectives:
razviti biološke označevalce za diagnosticiranje in zdravljenje bolezni, ki so jasno povezani s klinično ustreznostjo in jih odobrijo regulatorni organi;
to support, in accordance with Article 25 of Regulation (EU) No 1291/2013, the development and implementation of pre-competitive research and of innovation activities of strategic importance to the Union’s competitiveness and industrial leadership or to address specific societal challenges in particular as described in parts II and III of Annex I to Decision 2013/743/EU, and in particular the challenge to improve European citizens’ health and well-being;
znižati stopnjo neustreznosti kandidatov za cepljenje v III. fazi kliničnih preskušanj z novimi biološkimi označevalci za začetna preverjanja učinkovitosti in varnosti;
to contribute to the objectives of the Joint Technology Initiative on Innovative Medicines, in particular to:
izboljšati sedanji postopek razvoja zdravil z zagotavljanjem podpore za razvoj orodij, standardov in pristopov za ocenjevanje učinkovitosti, varnosti in kakovosti reguliranih medicinskih proizvodov.
increase the success rate in clinical trials of priority medicines identified by the World Health Organisation;
Člen 3
where possible, reduce the time to reach clinical proof of concept in medicine development, such as for cancer, immunological, respiratory, neurological and neurodegenerative diseases;
Finančni prispevek Unije
develop new therapies for diseases for which there is a high unmet need, such as Alzheimer’s disease and limited market incentives, such as antimicrobial resistance;
Finančni prispevek Unije za Skupno podjetje IMI2, vključno z odobritvami Efte, za kritje upravnih stroškov in stroškov poslovanja je 1638000000 EUR in vključuje:
develop diagnostic and treatment biomarkers for diseases clearly linked to clinical relevance and approved by regulators;
do 1425000000 EUR, kolikor znaša tudi prispevek Evropske zveze farmacevtske industrije in združenj (v nadaljnjem besedilu: EFPIA) ali njenih sestavnih subjektov ali njihovih pridruženih subjektov;
reduce the failure rate of vaccine candidates in phase III clinical trials through new biomarkers for initial efficacy and safety checks;
do 213000000 EUR, kolikor znašajo tudi dodatni prispevki drugih članov ali pridruženih partnerjev oziroma njihovih sestavnih subjektov ali njihovih pridruženih subjektov.
improve the current drug development process by providing support for the development of tools, standards and approaches to assess efficacy, safety and quality of regulated health products.
Prispevek Unije se plača iz odobritev splošnega proračuna Unije, dodeljenih posebnemu programu Obzorje 2020 za izvajanje Obzorje 2020 v skladu s točko (c)(iv) člena 58(1) ter členoma 60 in 61 Uredbe (EU, Euratom) št. 966/2012 za organe iz člena 209 navedene uredbe.
Article 3
Finančni prispevek Unije urejajo sporazum o prenosu pooblastil in sporazumi o letnem prenosu sredstev, ki jih skleneta Komisija v imenu Unije in Skupno podjetje IMI2.
Union financial contribution
Sporazum o prenosu pooblastil iz odstavka 2 tega člena zajema vidike, določene v členu 58(3) ter členih 60 in 61 Uredbe (EU, Euratom) št. 966/2012 in členu 40 Delegirane uredbe (EU) št. 1268/2012, med drugim tudi naslednje:
The Union financial contribution to the IMI2 Joint Undertaking, including EFTA appropriations, to cover administrative costs and operational costs shall be up to EUR 1638000000 and shall consist of the following:
zahteve za prispevek Skupnega podjetja IMI2 v zvezi z ustreznimi kazalniki uspešnosti iz Priloge II k Sklepu 2013/743/EU;
up to EUR 1425000000 to match the contribution of European Federation of Pharmaceutical Industries and Associations (‘EFPIA’), or its constituent entities or their affiliated entities;
zahteve za prispevek Skupnega podjetja IMI2 v zvezi s spremljanjem iz Priloge III k Sklepu 2013/743/EU;
up to EUR 213000000 to match additional contributions from other Members, Associated Partners, or from their constituent entities or their affiliated entities.
posebne kazalnike uspešnosti v zvezi z delovanjem Skupnega podjetja IMI2;
The contribution of the Union shall be paid from the appropriations in the general budget of the Union allocated to Horizon 2020 Specific Programme implementing Horizon 2020 in accordance with point (c)(iv) of Article 58(1) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012 for bodies referred to in Article 209 of that Regulation.
ureditve v zvezi s posredovanjem podatkov, potrebnih za zagotovitev, da lahko Komisija izpolnjuje svoje obveznosti glede razširjanja in poročanja, med drugim na enotnem portalu za udeležence ter prek drugih elektronskih sredstev razširjanja v okviru Obzorje 2020, ki jih upravlja Komisija;
The arrangements for the Union financial contribution shall be set out in a delegation agreement and annual transfer of funds agreements to be concluded between the Commission, on behalf of the Union, and the IMI2 Joint Undertaking.
določbe o objavi razpisov za zbiranje predlogov Skupnega podjetja IMI2, tudi na enotnem portalu za udeležence, pa tudi prek drugih sredstev elektronskega razširjanja v okviru Obzorje 2020, ki jih upravlja Komisija;
The delegation agreement referred to in paragraph 2 of this Article shall address the elements set out in Article 58(3) and Articles 60 and 61 of Regulation (EU, Euratom) No 966/2012 and in Article 40 of the Delegated Regulation (EU) No 1268/2012 as well as, inter alia, the following:
uporabo človeških virov in spremembe v zvezi z njimi, zlasti zaposlovanje po funkcionalnih skupinah, plačnih razredih in kategorijah, prerazporejanje in vse spremembe števila uslužbencev.
the requirements for the IMI2 Joint Undertaking’s contribution regarding the relevant performance indicators referred to in Annex II to Decision 2013/743/EU;
Člen 4
the requirements for the IMI2 Joint Undertaking’s contribution in view of the monitoring referred to in Annex III to Decision 2013/743/EU;
Prispevki članov razen Unije in prispevki pridruženih partnerjev
the specific performance indicators related to the functioning of the IMI2 Joint Undertaking;
Prispevki iz odstavka 1 tega člena so sestavljeni iz prispevkov za Skupno podjetje IMI2, kot so določeni v členu 13(2), točki (b) člena 13(3) in točki (c) člena 13(3) Statuta.
the arrangements regarding the provision of data necessary to ensure that the Commission is able to meet its dissemination and reporting obligations including on the single portal for participants as well as through other Horizon 2020 electronic means of dissemination managed by the Commission;
Prispevki v naravi, ki jih sestavljajo stroški, nastali v tretjih državah, ki niso države, pridružene z Obzorje 2020, so upravičeni in pomembni za cilje iz člena 2 te uredbe ter na ravni programa IMI2 ne presegajo 30 % upravičenih stroškov članov razen Unije in pridruženih partnerjev.
Article 4
Za oceno prispevkov iz točke (b) člena 13(3) Statuta se stroški določijo v skladu z običajnimi praksami stroškovnega računovodstva zadevnih subjektov, veljavnimi računovodskimi standardi države, v kateri ima subjekt sedež, in veljavnimi mednarodnimi računovodskimi standardi in mednarodnimi standardi računovodskega poročanja.
Contributions of Members other than the Union and of Associated Partners
Stroške potrdi neodvisni zunanji revizor, ki ga imenuje zadevni subjekt.
EFPIA shall make or arrange for its constituent entities or their affiliated entities to make contributions of at least EUR 1425000000.
Če je vsebina potrdila kakor koli nejasna, lahko Skupno podjetje IMI 2 preveri metodo, po kateri se je ocenila vrednost.
Other Members other than the Union and Associated Partners shall make, or arrange for their constituent entities or their affiliated entities to make, the contributions corresponding to the amounts they have committed when becoming a Member or an Associated Partner.
V primeru negotovosti jih lahko revidira Skupno podjetje IMI2.
The contributions referred to in paragraph 1 of this Article shall consist of contributions to the IMI2 Joint Undertaking as set out in Article 13(2), point (b) of Article 13(3) and point (c) of Article 13(3) of the Statutes.
Komisija lahko prekliče, sorazmerno zmanjša ali začasno ustavi finančni prispevek Unije za Skupno podjetje IMI2 ali začne postopek za prenehanje delovanja podjetja iz člena 21(2) Statuta, če navedeni člani in pridruženi partnerji, njihovi sestavni subjekti ali njihovi pridruženi subjekti prispevkov iz odstavka 2 tega člena ne plačujejo, jih plačujejo samo delno ali z zamudo.
In-kind contributions consisting of costs incurred in third countries other than countries associated to Horizon 2020 shall be justified and relevant to the objectives set out in Article 2 of this Regulation, and shall not exceed 30 % of the eligible costs at the level of the IMI2 programme, incurred by the Members other than the Union and by the Associated Partners.
Člen 5
The Members other than the Union and Associated Partners shall report each year by 31 January to the Governing Board of the IMI2 Joint Undertaking on the value of the contributions referred to in paragraph 2 made in each of the previous financial years.
Finančna pravila
The States Representatives Group shall also be informed thereof in a timely manner.
Brez poseganja v člen 12 te uredbe Skupno podjetje IMI2 sprejme posebna finančna pravila v skladu s členom 209 Uredbe (EU, Euratom) št. 966/2012 in Delegirano uredbo Komisije (EU) št. 110/2014 [9].Člen 6
For the purpose of valuing the contributions referred to in point (b) of Article 13(3) of the Statutes, the costs shall be determined in accordance with the usual cost accounting practices of the entities concerned, to the applicable accounting standards of the country where the entity is established, and to the applicable International Accounting Standards and International Financial Reporting Standards.
Osebje
The costs shall be certified by an independent external auditor appointed by the entity concerned.
Za osebje Skupnega podjetja IMI2 se uporabljajo Kadrovski predpisi za uradnike in Pogoji za zaposlitev drugih uslužbencev Evropske unije, določeni z Uredbo Sveta (EGS, Euratom, ESPJ) št. 259/68 [10] (v nadaljnjem besedilu: Kadrovski predpisi in Pogoji za zaposlitev), ter pravila, sprejeta skupno med institucijami Unije za namene uporabe Kadrovskih predpisov in Pogojev za zaposlitev.
The valuation method may be verified by the IMI2 Joint Undertaking should there be any uncertainty arising from the certification.
Upravni odbor v zvezi z osebjem Skupnega podjetja IMI2 izvaja pooblastila, ki so s Kadrovskimi predpisi podeljena organu za imenovanja, s Pogoji za zaposlitev drugih uslužbencev pa organu, pristojnemu za sklepanje pogodb (v nadaljnjem besedilu: pooblastila organa za imenovanja).
In case of remaining uncertainties, it may be audited by the IMI2 Joint Undertaking.
Upravni odbor v skladu s členom 110 Kadrovskih predpisov sprejme odločitev na podlagi člena 2(1) Kadrovskih predpisov in člena 6 Pogojev za zaposlitev o prenosu ustreznih pooblastil organa za imenovanje na izvršnega direktorja in o opredelitvi pogojev, v skladu s katerimi se lahko ta prenos pooblastil začasno prekine.
The Commission may terminate, proportionally reduce or suspend the Union financial contribution to the IMI2 Joint Undertaking or trigger the winding up procedure referred to in Article 21(2) of the Statutes if those Members and Associated Partners, their constituent entities or their affiliated entities do not contribute, contribute only partially or contribute late with regard to the contributions referred to in paragraph 2 of this Article.
Izvršni direktor ima dovoljenje za nadaljnji prenos navedenih pooblastil.
Article 5
Upravni odbor lahko zaradi izjemnih okoliščin s sklepom začasno prekine prenos pooblastil organa za imenovanje na izvršnega direktorja in vseh kasnejših pooblastil, ki jih je ta prenesel naprej.
Financial rules
V takem primeru upravni odbor pooblastila organa za imenovanja izvaja sam ali jih prenese na enega od svojih članov ali člana osebja Skupnega podjetja IMI2, razen izvršnega direktorja.
Without prejudice to Article 12 of this Regulation, the IMI2 Joint Undertaking shall adopt its specific financial rules in accordance with Article 209 of Regulation (EU, Euratom) No 966/2012 and Commission Delegated Regulation (EU) No 110/2014 [9].Article 6
Upravni odbor sprejme ustrezna izvedbena pravila h Kadrovskim predpisom in Pogojem za zaposlitev v skladu s členom 110 Kadrovskih predpisov.
Staff
Število osebja se določi v načrtu delovnih mest Skupnega podjetja IMI2, v katerem sta navedeni število začasnih delovnih mest po funkcionalnih skupinah in plačnih razredih ter število pogodbenih uslužbencev v ekvivalentu polnega delovnega časa, v skladu z letnim proračunom Skupnega podjetja IMI2.
The Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Union as laid down by Council Regulation (EEC, Euratom, ECSC) No 259/68 [10] (hereinafter ‘Staff Regulations’ and ‘Conditions of Employment’) and the rules adopted jointly by the institutions of the Union for the purpose of applying Staff Regulations and Conditions of Employment shall apply to the staff of the IMI2 Joint Undertaking.
Osebje Skupnega podjetja IMI2 so začasni uslužbenci in pogodbeni uslužbenci.
The Governing Board shall exercise, with respect to the staff of the IMI2 Joint Undertaking, the powers conferred by the Staff Regulations on the Appointing Authority and the powers conferred by the Conditions of Employment on the authority empowered to conclude contract (hereinafter ‘the appointing authority powers’).
Vse stroške v zvezi z osebjem krije Skupno podjetje IMI2.
The Governing Board shall adopt, in accordance with Article 110 of the Staff Regulations, a decision based on Article 2(1) of the Staff Regulations and on Article 6 of the Conditions of Employment delegating the relevant appointing authority powers to the Executive Director and defining the conditions under which that delegation may be suspended.
Člen 7
The Executive Director shall be authorised to sub-delegate those powers.
Napoteni nacionalni strokovnjaki in pripravniki
Where exceptional circumstances so require, the Governing Board may by decision temporarily suspend the delegation of the appointing authority powers to the Executive Director and any subsequent sub-delegation of those powers by the latter.
Skupno podjetje IMI2 lahko uporabi napotene nacionalne strokovnjake in pripravnike, ki niso zaposleni v Skupnem podjetju IMI2.
In such cases the Governing Board shall exercise the appointing authority powers itself or shall delegate them to one of its members or to a staff member of the IMI2 Joint Undertaking other than the Executive Director.
Število napotenih nacionalnih strokovnjakov, izraženo v ekvivalentih polnega delovnega časa, se prišteje podatkom o osebju iz člena 6(4) v skladu z letnim proračunom.
The Governing Board shall adopt appropriate implementing rules to the Staff Regulations and the Conditions of Employment in accordance with Article 110 of the Staff Regulations.
Upravni odbor sprejme sklep, s katerim določi pravila o napotitvi nacionalnih strokovnjakov v Skupno podjetje IMI2 in uporabi pripravnikov.
The staff resources shall be determined in the staff establishment plan of the IMI2 Joint Undertaking indicating the number of temporary posts by function group and by grade and the number of contract staff expressed in full-time equivalents, in line with its annual budget.
Člen 8
The staff of the IMI2 Joint Undertaking shall consist of temporary staff and contract staff.
Privilegiji in imunitete
All costs related to the staff shall be borne by the IMI2 Joint Undertaking.
Za Skupno podjetje IMI2 in njegovo osebje se uporablja Protokol (št. 7) o privilegijih in imunitetah Evropske unije, ki je priložen Pogodbi o Evropski uniji in PDEU.
Article 7
Člen 9
Seconded national experts and trainees
Odgovornost Skupnega podjetja IMI2
The IMI2 Joint Undertaking may make use of seconded national experts and trainees not employed by the IMI2 Joint Undertaking.
Pogodbeno odgovornost Skupnega podjetja IMI2 urejajo ustrezne pogodbene določbe in pravo, ki se uporablja za zadevni sporazum, sklep ali pogodbo.
The number of seconded national experts expressed in full-time equivalents shall be added to the information on staff as referred to in Article 6(4) in line with the annual budget.
V primeru nepogodbene odgovornosti Skupno podjetje IMI2 v skladu s splošnimi pravnimi načeli, ki so skupna vsem državam članicam nadomesti vso škodo, ki jo je povzročilo njegovo osebje pri opravljanju svojih dolžnosti.
The Governing Board shall adopt a decision laying down rules on the secondment of national experts to the IMI2 Joint Undertaking and on the use of trainees.
Vsako plačilo Skupnega podjetja IMI2 v zvezi z odgovornostjo iz odstavkov 1 ali 2 ter stroški in izdatki, nastali v povezavi s tem, se štejejo za odhodke Skupnega podjetja IMI2 in se krijejo iz njegovih sredstev.
Article 8
Skupno podjetje IMI2 je edino odgovorno za izpolnjevanje svojih obveznosti.
Privileges and Immunities
Člen 10
The Protocol No 7 on the privileges and immunities of the European Union, annexed to the Treaty on European Union and the Treaty on the Functioning of the European Union, shall apply to the IMI2 Joint Undertaking and its staff.
Pristojnost Sodišča Evropske unije in pravo, ki se uporablja
Article 9
Sodišče Evropske unije je pristojno:
Liability of the IMI2 Joint Undertaking
na podlagi arbitražnih klavzul v sporazumih ali pogodbah, ki jih sklene Skupno podjetje IMI2, ali njegovih sklepih;
The contractual liability of the IMI2 Joint Undertaking shall be governed by the relevant contractual provisions and by the law applicable to the agreement, decision or contract in question.
v sporih v zvezi z nadomestilom škode, ki jo je povzročilo osebje Skupnega podjetja IMI2 pri opravljanju svojih dolžnosti;
In the case of non-contractual liability, the IMI2 Joint Undertaking shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its staff in the performance of their duties.
v sporih med Skupnim podjetjem IMI2 in njegovim osebjem v okvirih in pod pogoji, določenimi v Kadrovskih predpisih in Pogojih za zaposlitev.
Any payment by the IMI2 Joint Undertaking in respect of the liability referred to in paragraphs 1 or 2 and the costs and expenses incurred in connection therewith shall be considered as expenditure of the IMI2 Joint Undertaking and shall be covered by its resources.
Za vse zadeve, ki jih ne urejajo ta uredba ali drugi pravni akti Unije, se uporablja pravo države, v kateri je sedež Skupnega podjetja IMI2.
The IMI2 Joint Undertaking shall be solely responsible for meeting its obligations.
Člen 11
Article 10
Ocena
Jurisdiction of the Court of Justice of the European Union and applicable law
Komisija do 30. junija 2017 s pomočjo neodvisnih strokovnjakov izvede vmesno oceno Skupnega podjetja IMI2.
The Court of Justice of the European Union shall have jurisdiction:
O tej oceni pripravi poročilo, ki vključuje ugotovitve ocene in pripombe Komisije.
pursuant to any arbitration clause contained in agreements or contracts concluded by the IMI2 Joint Undertaking or in its decisions;
Navedeno poročilo do 31. decembra 2017 predloži Evropskemu parlamentu in Svetu.
in disputes relating to compensation for damage caused by the staff of the IMI2 Joint Undertaking in the performance of their duties;
Rezultati vmesne ocene Skupnega podjetja IMI2 se upoštevajo pri poglobljeni oceni in vmesni oceni iz člena 32 Uredbe (EU) št. 1291/2013.
in any dispute between the IMI2 Joint Undertaking and its staff within the limits and under the conditions laid down in the Staff Regulations and the Conditions of Employment.
Komisija lahko na podlagi ugotovitev vmesne ocene iz odstavka 1 tega člena ukrepa v skladu s členom 4(5) ali sprejme druge ustrezne ukrepe.
Regarding any matter not covered by this Regulation or by other Union legal acts, the law of the State where the seat of the IMI2 Joint Undertaking is located shall apply.
V šestih mesecih od prenehanja delovanja Skupnega podjetja IMI2, vendar najpozneje v dveh letih po začetku postopka za prenehanje delovanja iz člena 21 Statuta, pripravi končno oceno Skupnega podjetja IMI2.
Article 11
Rezultati navedene končne ocene se predložijo Evropskemu parlamentu in Svetu.
Evaluation
Člen 12
By 30 June 2017 the Commission shall carry out, with the assistance of independent experts, an interim evaluation of the IMI2 Joint Undertaking.
Razrešnica