{"status":"OK","data":{"advertisement":{"id":286765,"title":"EDPI/2/PR93893/86522-217685/2025 - Opracowanie i rozw\u00f3j wziewnych z\u0142o\u017conych lek\u00f3w generycznych w terapii chor\u00f3b uk\u0142adu oddechowego PoChP i astmy","partial_offer_allowed":false,"publication_date":"2025-02-28","submission_deadline":"2025-03-10 23:59:59","planned_sign_date":"2025-03-01","supplementary_orders":null,"terms_of_contract_change":"Zamawiaj\u0105cy zastrzega sobie mo\u017cliwo\u015b\u0107 dokonania istotnych zmian postanowie\u0144 zawartej umowy w stosunku do tre\u015bci oferty, na podstawie kt\u00f3rej dokonano wyboru Wykonawcy, w nast\u0119puj\u0105cym zakresie i sytuacjach:\n- zmiany przepis\u00f3w prawa Unii Europejskiej lub prawa krajowego w zakresie maj\u0105cym wp\u0142yw na realizacj\u0119 Umowy (w szczeg\u00f3lno\u015bci zmiany stawek podatku VAT);\n- poprawienia parametr\u00f3w technicznych przedmiotu zam\u00f3wienia, bez wp\u0142ywu na cen\u0119 rycza\u0142tow\u0105 netto,\n- przed\u0142u\u017cenia terminu realizacji zam\u00f3wienia z uwagi na potrzeb\u0119 wykonania prac dodatkowych, kt\u00f3rych wykonanie jest niezb\u0119dne do nale\u017cytego wykonania umowy, a kt\u00f3rych wykonania Zamawiaj\u0105cy, dzia\u0142aj\u0105c z nale\u017cyt\u0105 staranno\u015bci\u0105, nie m\u00f3g\u0142 wcze\u015bniej przewidzie\u0107;\n- przed\u0142u\u017cenia terminu realizacji zam\u00f3wienia na skutek dzia\u0142ania si\u0142y wy\u017cszej wraz ze wszystkimi konsekwencjami wyst\u0119puj\u0105cymi w zwi\u0105zku z przed\u0142u\u017ceniem tego terminu;\n- przed\u0142u\u017cenia terminu realizacji zam\u00f3wienia z innych przyczyn niezale\u017cnych od Wykonawcy;\n- zmiany parametr\u00f3w przedmiotu umowy, zmiana zakresu rzeczowego umowy oraz zmiana sposobu wykonania zam\u00f3wienia, nie prowadz\u0105ce do zmiany charakteru umowy \u2013 zmiany technologiczne, w szczeg\u00f3lno\u015bci: konieczno\u015b\u0107 realizacji zam\u00f3wienia przy zastosowaniu innych rozwi\u0105za\u0144 technicznych/technologicznych, materia\u0142owych ni\u017c wskazane w zapytaniu ofertowym, w sytuacji, gdy zastosowanie przewidzianych rozwi\u0105za\u0144 grozi\u0142oby niewykonaniem lub wadliwym wykonaniem umowy;\n- zmiany wymienione w sekcji 3.2.4 pkt 4 Wytycznych dotycz\u0105cych kwalifikowalno\u015bci wydatk\u00f3w na lata 2021-2027.\n- Zamawiaj\u0105cy przewiduje r\u00f3wnie\u017c mo\u017cliwo\u015b\u0107 dokonywania nieistotnych zmian postanowie\u0144 zawartej umowy w stosunku do tre\u015bci oferty, na podstawie kt\u00f3rej dokonano wyboru Wykonawcy.\n- Zmiany umowy wprowadzane b\u0119d\u0105 w formie aneksu podpisanego przez obie strony a mo\u017cliwo\u015b\u0107 ich wprowadzenia uzale\u017cniona jest od akceptacji przez Zamawiaj\u0105cego.\n\nAMENDMENT OF THE CONTRACT TERMS\nThe Contracting Authority reserves the right to make significant changes to the provisions of the concluded contract in relation to the content of the offer on the basis of which the Contractor was selected, in the following scope and situations: \n- changes in European Union or national law affecting the implementation of the Contract (in particular changes in VAT rates); \n- improvement of the technical parameters of the subject of the contract, without affecting the net lump sum price; \n- extension of the contract execution period due to the need to perform additional work necessary for the proper execution of the contract, which the Contracting Authority, acting with due diligence, could not have foreseen earlier; \n- extension of the contract execution period due to force majeure, along with all consequences arising from the extension of this period; \n- extension of the contract execution period for other reasons beyond the Contractor's control; \n- changes in the parameters of the subject of the contract, changes in the scope of the contract, and changes in the method of execution of the contract, not leading to a change in the nature of the contract \u2013 technological changes, in particular: the necessity to execute the contract using different technical/technological or material solutions than those indicated in the request for proposal, in situations where the use of the envisaged solutions would threaten the non-performance or defective performance of the contract; \n- changes listed in section 3.2.4 point 4 of the Guidelines on the eligibility of expenses for 2021-2027. \n- The Contracting Authority also foresees the possibility of making insignificant changes to the provisions of the concluded contract in relation to the content of the offer on the basis of which the Contractor was selected. \n- Contract changes will be introduced in the form of an annex signed by both parties, and the possibility of their introduction depends on the acceptance by the Contracting Authority.","created_at":"2025-02-28 10:22:28","modified_at":"2025-03-11 00:00:14","contact_persons":[{"id":85258,"forename":"Pawe\u0142","surname":"Brzezi\u0144ski","phone_number":"","email":"pawel.brzezinski@polpharma.com","created_by":null,"created_at":"2025-04-24 14:04:09","modified_at":"2025-04-24 14:04:09","modified_by":null}],"orders":[{"id":465449,"estimated_value":null,"order_items":[{"id":525148,"description":"Przedmiotem zam\u00f3wienia jest us\u0142uga dotycz\u0105ca opracowania i wytworzenia prototypu inhalatora.\nSzczeg\u00f3\u0142owy opis przedmiotu zam\u00f3wienia jest obj\u0119ty ochron\u0105 tajemnicy przedsi\u0119biorstwa w rozumieniu przepis\u00f3w ustawy z dnia 16 kwietnia 1993 r. o zwalczaniu nieuczciwej konkurencji (Dz. U. z 2022 r. poz. 1233, z p\u00f3\u017an. zm.) i ich przekazanie wymaga zawarcia stosownej umowy o zachowaniu poufno\u015bci (ang. Non-Disclosure Agreement, NDA), stanowi\u0105cej Za\u0142\u0105cznik nr 6 do niniejszego zapytania ofertowego. \nZa\u0142\u0105cznik nr 5 zostanie przez Zamawiaj\u0105cego udost\u0119pniony w ci\u0105gu 2 dni roboczych od podpisania obustronnie umowy o zachowaniu poufno\u015bci podpisanej podpisem elektronicznym (przez platform\u0119 DocuSign. Umowa musi zosta\u0107 uzupe\u0142niona i podpisana przez osob\u0119 upowa\u017cnion\u0105 do reprezentowania Oferenta lub posiadaj\u0105c\u0105 odpowiednie pe\u0142nomocnictwo. Do umowy o zachowaniu poufno\u015bci nale\u017cy za\u0142\u0105czy\u0107 pe\u0142nomocnictwo i/lub odpis z w\u0142a\u015bciwego rejestru potwierdzaj\u0105cy upowa\u017cnienie do reprezentacji. \n\nThe subject of the contract is a service related to the development and production of an inhaler prototype.\nA detailed description of the subject of the contract is protected as a trade secret under the provisions of the Act of April 16, 1993, on combating unfair competition (Journal of Laws of 2022, item 1233, as amended) and its disclosure requires the conclusion of a relevant confidentiality agreement (Non-Disclosure Agreement, NDA), which constitutes Appendix No. 6 to this request for proposal.\nAppendix No. 5 will be made available by the Contracting Authority within 2 working days from the signing of the mutual confidentiality agreement signed with an electronic signature (via the DocuSign platform). The agreement must be completed and signed by a person authorized to represent the Bidder or holding the appropriate power of attorney. The confidentiality agreement must be accompanied by a power of attorney and/or an excerpt from the relevant register confirming the authorization to represent.","warranty_period":null,"cpv_items":[{"id":2879,"code":"33157000-5","name":"Urz\u0105dzenia do terapii gazowej i oddechowej"},{"id":3113,"code":"33670000-7","name":"\u015arodki lecznicze dla uk\u0142adu oddechowego"},{"id":8513,"code":"73100000-3","name":"Us\u0142ugi badawcze i eksperymentalno-rozwojowe"}],"timetable_items":[],"fulfillment_places":[{"country":"Polska","voivodeship":"\u0142\u00f3dzkie","poviat":"sieradzki","commune":"Sieradz","locality":"Sieradz","created_by":null,"created_at":"2025-02-28 10:22:28","modified_at":"2025-02-28 15:51:17","modified_by":null,"id":592769,"type":{"id":1,"name":"adres"},"group_uuid":"18f4b5c2-5935-4359-b1d7-3792edf8e5f4"}],"participation_conditions":[{"id":1462574,"description":"Posiada system zarz\u0105dzania jako\u015bci\u0105 w zakresie projektowania i produkcji wyrob\u00f3w medycznych potwierdzonego certyfikatem ISO 13485.\nZamawiaj\u0105cy uzna, \u017ce Oferent spe\u0142nia niniejszy warunek, je\u017celi z\u0142o\u017cy o\u015bwiadczenie, \u017ce dysponuje uprawnieniami niezb\u0119dnymi do prawid\u0142owej realizacji zam\u00f3wienia.\n\nPossess a quality management system for the design and production of medical devices confirmed by ISO 13485 certification.\nThe Contracting Authority will consider that the Bidder meets this condition if they submit a statement that they have the necessary authorizations for the proper execution of the contract.","type":{"id":1,"name":"Uprawnienia do wykonywania okre\u015blonej dzia\u0142alno\u015bci lub czynno\u015bci"},"created_by":null,"created_at":"2025-02-28 10:22:28","modified_at":"2025-02-28 15:51:17","modified_by":null,"group_uuid":"6eb8543a-f84c-49e6-81d0-7ffc9d2f61fb"},{"id":1462575,"description":"Posiada udokumentowane do\u015bwiadczenie w zakresie projektowania i rozwoju wyrob\u00f3w medycznych s\u0142u\u017c\u0105cych do inhalacji, kt\u00f3re s\u0105 stosowane w terapii chor\u00f3b uk\u0142adu oddechowego POCHP i astmy co najmniej 3 lata.\nSpecjalizuje si\u0119 w rozwoju generycznych inhalator\u00f3w do zastosowa\u0144 w przemy\u015ble farmaceutycznym, co najmniej 3 lata.\nPosiada wiedz\u0119 i do\u015bwiadczenie w zakresie projektowania i formowania element\u00f3w z tworzyw sztucznych metod\u0105 wtrysku, co najmniej 3 lata.\nZamawiaj\u0105cy uzna, \u017ce Oferent spe\u0142nia niniejszy warunek, je\u017celi z\u0142o\u017cy o\u015bwiadczenie, \u017ce dysponuje wiedz\u0105 i do\u015bwiadczeniem niezb\u0119dnymi do prawid\u0142owej realizacji zam\u00f3wienia.\n\nHave documented experience in the design and development of medical devices for inhalation used in the treatment of respiratory diseases COPD and asthma for at least 3 years.\nSpecialize in the development of generic inhalers for use in the pharmaceutical industry for at least 3 years.\nHave knowledge and experience in the design and molding of plastic components by injection molding for at least 3 years.\nThe Contracting Authority will consider that the Bidder meets this condition if they submit a statement that they have the knowledge and experience necessary for the proper execution of the contract.","type":{"id":2,"name":"Wiedza i do\u015bwiadczenie"},"created_by":null,"created_at":"2025-02-28 10:22:28","modified_at":"2025-02-28 15:51:17","modified_by":null,"group_uuid":"fc4d5ae6-c8ce-410e-9d53-8830f529be5b"},{"id":1462576,"description":"Posiada zdolno\u015b\u0107 projektowania i wytwarzania wyrob\u00f3w medycznych s\u0142u\u017c\u0105cych do podawania lek\u00f3w wziewnych (inhalator\u00f3w) zgodnie z norm\u0105 ISO 13485.\nPosiada zak\u0142ad produkcyjny wyrob\u00f3w medycznych do inhalacji certyfikowany norm\u0105 ISO 13485 (aktualny certyfikat w okresie realizacji us\u0142ugi i planowany do utrzymania w przysz\u0142o\u015bci).\nZamawiaj\u0105cy uzna, \u017ce Oferent spe\u0142nia niniejszy warunek, je\u017celi z\u0142o\u017cy o\u015bwiadczenie, \u017ce dysponuje zapleczem technicznym niezb\u0119dnym do prawid\u0142owej realizacji zam\u00f3wienia oraz przedstawi certyfikat ISO 13485.\n\nHave the ability to design and manufacture medical devices for the administration of inhaled drugs (inhalers) in accordance with iso 13485.\nHave a production facility for inhalation medical devices certified by iso 13485 (current certificate during the service period and planned to be maintained in the future).\nThe Contracting Authority will consider that the Bidder meets this condition if they submit a statement that they have the technical facilities necessary for the proper execution of the contract and present the ISO 13485 certificate.","type":{"id":3,"name":"Potencja\u0142 techniczny"},"created_by":null,"created_at":"2025-02-28 10:22:28","modified_at":"2025-02-28 15:51:17","modified_by":null,"group_uuid":"62593c5e-9317-476c-8c5c-b31370024cc8"},{"id":1462577,"description":"Zamawiaj\u0105cy uzna, \u017ce Oferent spe\u0142nia niniejszy warunek, je\u017celi z\u0142o\u017cy o\u015bwiadczenie, \u017ce dysponuje zasobami ludzkimi niezb\u0119dnymi do prawid\u0142owej realizacji zam\u00f3wienia. W\u015br\u00f3d kluczowych zasob\u00f3w powinni si\u0119 znale\u017a\u0107:\n\u2022\tSpecjalista ds. dokumentacji (wymagania do spe\u0142nienia: wykszta\u0142cenie wy\u017csze, udokumentowane do\u015bwiadczenie w zakresie przygotowania dokument\u00f3w projektowych, m.in. dokumentacji technicznej wyrobu, projektowania itp.)\n\u2022\tKonstruktor (wymagania do spe\u0142nienia: wykszta\u0142cenie techniczne, znajomo\u015b\u0107 program\u00f3w AutoCad, Inventor lub pokrewnych, praktyczna i teoretyczna wiedza z zakresu rysunku technicznego oraz wymiarowania, do\u015bwiadczenia w projektach wdro\u017ceniowych wyrob\u00f3w medycznych)\n\u2022\tIn\u017cynier produktu (wymagania do spe\u0142nienia: wykszta\u0142cenie wy\u017csze techniczne, znajomo\u015b\u0107 program\u00f3w AutoCad, Inventor lub pokrewnych, udokumentowane do\u015bwiadczenie w zakresie wytwarzania komponent\u00f3w tworzywowych metod\u0105 wtrysku) \n\u2022\tOsoba odpowiedzialna za wytworzenie komponent\u00f3w inhalatora - operator wtryskarki \n\u2022\tOsoba odpowiedzialna za monta\u017c inhalatora \n\u2022\tOsoba odpowiedzialna za kontrol\u0119 jako\u015bci \n\u2022\tOsoba odpowiedzialna za nadz\u00f3r and jako\u015bci\u0105 \nKa\u017cda z wy\u017cej wymienionych os\u00f3b powinna posiada\u0107 do\u015bwiadczenie w pracy z wyrobami medycznymi oraz znajomo\u015b\u0107 normy ISO 13485.\n\nThe Contracting Authority will consider that the Bidder meets this condition if they submit a statement that they have the human resources necessary for the proper execution of the contract. Key resources should include:\n\u2022\tDocumentation Specialist (requirements: higher education, documented experience in preparing project documents, including technical product documentation, design, etc.)\n\u2022\tDesigner (requirements: technical education, knowledge of AutoCad, Inventor, or similar programs, practical and theoretical knowledge of technical drawing and dimensioning, experience in implementation projects of medical devices)\n\u2022\tProduct Engineer (requirements: higher technical education, knowledge of AutoCad, Inventor, or similar programs, documented experience in manufacturing plastic components by injection molding)\n\u2022\tPerson responsible for the production of inhaler components - injection molding machine operator\n\u2022\tPerson responsible for assembling the inhaler\n\u2022\tPerson responsible for quality control\n\u2022\tPerson responsible for quality supervision\nEach of the above-mentioned persons should have experience working with medical devices and knowledge of ISO 13485.","type":{"id":4,"name":"Osoby zdolne do wykonania zam\u00f3wienia"},"created_by":null,"created_at":"2025-02-28 10:22:28","modified_at":"2025-02-28 15:51:17","modified_by":null,"group_uuid":"99f6f097-bcdc-48e1-8bae-23e4fdf78a11"},{"id":1462578,"description":"Zamawiaj\u0105cy uzna, \u017ce Oferent spe\u0142nia niniejszy warunek, je\u017celi z\u0142o\u017cy o\u015bwiadczenie, \u017ce znajduje si\u0119 w sytuacji ekonomicznej i finansowej zapewniaj\u0105cej prawid\u0142ow\u0105 realizacj\u0119 zam\u00f3wienia, w szczeg\u00f3lno\u015bci nie znajduje si\u0119 w stanie upad\u0142o\u015bci, restrukturyzacji lub likwidacji.\nO\u015bwiadczenie dotycz\u0105ce spe\u0142nienia warunk\u00f3w opisanych w pkt. VI stanowi Za\u0142\u0105cznik nr 4 do Zapytania Ofertowego.\nZamawiaj\u0105cy zastrzega prawo do wezwania Wykonawcy do przedstawienia dokumentacji w celu potwierdzenia informacji zawartych w o\u015bwiadczeniu.\n\nThe Contracting Authority will consider that the Bidder meets this condition if they submit a statement that they are in an economic and financial situation ensuring the proper execution of the contract, in particular, they are not in a state of bankruptcy, restructuring, or liquidation.\nThe statement regarding the fulfillment of the conditions described in point VI constitutes Appendix No. 4 to the Request for Proposal. The Contracting Authority reserves the right to request the Contractor to present documentation to confirm the information contained in the statement.","type":{"id":5,"name":"Sytuacja ekonomiczna i finansowa"},"created_by":null,"created_at":"2025-02-28 10:22:28","modified_at":"2025-02-28 15:51:17","modified_by":null,"group_uuid":"66d8d999-4bb1-4515-9b77-9ab91a8f4a98"},{"id":1462579,"description":"Podpisanie umowy o zachowaniu poufno\u015bci w celu udost\u0119pnienia szczeg\u00f3\u0142owego opisu przedmiotu zam\u00f3wienia (Za\u0142\u0105cznik nr 5).\n\nSigning a confidentiality agreement in order to share a detailed description of the subject of the order (Attachement No. 5).","type":{"id":7,"name":"Dodatkowe warunki udzia\u0142u"},"created_by":null,"created_at":"2025-02-28 10:22:28","modified_at":"2025-02-28 15:51:17","modified_by":null,"group_uuid":"936b5139-2e21-4724-89f5-8357724b728b"}],"category":{"id":1,"name":"Us\u0142uga"},"subcategory":{"id":4,"name":"Us\u0142ugi badawcze"},"created_by":null,"created_at":"2025-02-28 10:22:28","modified_at":"2025-02-28 15:51:17","modified_by":null,"group_uuid":"6137a4e4-2de8-44e1-8022-40c185ccb2f9"}],"evaluation_criteria":[{"id":816946,"price_criterion":true,"description":"Cena 100% / Price 100%\nPc=Cn/Cb*100","created_by":null,"created_at":"2025-02-28 10:22:28","modified_at":"2025-02-28 15:51:17","modified_by":null,"group_uuid":"41be2f89-a06f-4a59-8cdc-d763b083abf7"}],"is_variant":false,"title":"Opracowanie i wytworzenie prototypu inhalatora.","order_node":{"id":352601},"created_by":null,"created_at":"2025-02-28 10:22:28","modified_at":"2025-02-28 15:51:17","modified_by":null}],"created_by":{"id":86522,"contact_persons":[]},"modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":2,"label":"PUBLISHED","name":"Opublikowane"},"advertiser_address_details":{"name":"Zak\u0142ady Farmaceutyczne Polpharma S.A.","identification_number_type":"nip","identification_number":"5920202822","address":{"country":"Polska","voivodeship":"pomorskie","poviat":"starogardzki","commune":"Starogard Gda\u0144ski","locality":"Starogard Gda\u0144ski","created_by":{"id":86522,"contact_persons":[]},"created_at":"2025-02-28 10:22:28","modified_at":"2025-02-28 10:22:28","modified_by":{"id":86522,"contact_persons":[]},"id":791526,"street":"Pelpli\u0144ska","number_description":"19","postcode":"83-200"},"created_by":{"id":86522,"contact_persons":[]},"created_at":"2025-02-28 10:22:28","modified_at":"2025-02-28 10:22:28","modified_by":{"id":86522,"contact_persons":[]},"id":287523},"advertisement":{"id":217685,"number":"2025-86522-217685","publication_date":"2025-02-28","created_by":{"id":86522,"contact_persons":[]},"created_at":"2025-02-28 10:22:28","modified_at":"2025-03-11 00:00:14","modified_by":{"modified_by":null,"id":1,"contact_persons":[]},"status":{"id":6,"label":"RESOLVED","name":"Rozstrzygni\u0119te"},"all_available_version_ids":[286765],"enrollment":null,"projects":[{"id":55612,"name":"Opracowanie i rozw\u00f3j wziewnych z\u0142o\u017conych lek\u00f3w generycznych w terapii chor\u00f3b uk\u0142adu oddechowego PoChP i astmy.","number":"0237/24","activity":{"created_by":{"id":114,"contact_persons":[{"id":43,"forename":"Anna","surname":"Nowak","phone_number":"111222333","email":"anna@email.com","created_at":"2026-08-26 10:58:57","modified_at":"2026-08-26 10:58:57"}]},"created_at":"2024-04-11 14:38:23","modified_at":"2025-02-20 10:12:44","modified_by":{"id":114,"contact_persons":[{"id":43,"forename":"Anna","surname":"Nowak","phone_number":"111222333","email":"anna@email.com","created_at":"2026-08-26 10:58:57","modified_at":"2026-08-26 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