{"status":"OK","data":{"advertisement":{"id":297785,"title":"EDPI/3/PR93893/2025-86522-224118 - 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":"2025-04-24","submission_deadline":"2025-04-29 23:59:59","planned_sign_date":"2025-05-01","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- zmian wymienionych w sekcji 7.3 pkt. 22 dokumentu \u201eKatalog kwalifikowalnych wydatk\u00f3w\u201d.\nZamawiaj\u0105cy przewiduje mo\u017cliwo\u015b\u0107 doprecyzowania i/lub uszczeg\u00f3\u0142owienia powy\u017cszych zapis\u00f3w, je\u017celi taka konieczno\u015b\u0107 wyniknie m.in. ze specyfiki przedmiotu zam\u00f3wienia i/lub wp\u0142ynie pozytywnie na w\u0142a\u015bciwe zrozumienie tre\u015bci zapisu i/lub usystematyzuje zasady wykonywania Umowy. \nZamawiaj\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.\nZmiany 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\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 quotation, 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 7.3, point 22 of the document \"Catalogue of eligible expenses\". \nThe Contracting Authority envisages the possibility of clarifying and/or detailing the above provisions if such a need arises, among others, from the specificity of the subject of the order and/or has a positive impact on the proper understanding of the content of the provision and/or systematizes the principles of performing the Agreement.\nThe 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. \nContract 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":"2025-04-24 14:04:09","modified_at":"2025-04-30 00:00:28","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":483293,"estimated_value":null,"order_items":[{"id":544993,"description":"W dniu 24.04.2025 dokonano zmiany w tre\u015bci zapytania cenowego, szczeg\u00f3\u0142y w za\u0142\u0105czniku \"ZMIANA TRE\u015aCI ZAPYTANIA CENOWEGO EDPI_3_PR93893_2025-86522-224118_24_04_2025\" oraz \"Zmienione Zapytanie ofertowe EDPI_3_PR93893_2025-86522-224118_24_04_2025\" \n\nOn 24.04.2025, a change was made to the content of the price inquiry, details in the attachment \"ZMIANA TRE\u015aCI ZAPYTANIA CENOWEGO EDPI_3_PR93893_2025-86522-224118_24_04_2025\" and \"Changed Request for Price EDPI_3_PR93893_2025-86522-224118_24_04_2025\"\n\n\nPrzedmiotem 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 udost\u0119pniony przez Zamawiaj\u0105cego Oferentowi w terminie 2 dni roboczych od dnia otrzymania podpisanej przez Oferenta podpisem elektronicznym lub w podpisem tradycyjnym umowy o zachowaniu poufno\u015bci. Umowa musi zosta\u0107 uzupe\u0142niona i podpisana przez osob\u0119 upowa\u017cnion\u0105 do reprezentowania Oferenta lub posiadaj\u0105c\u0105 stosowne pe\u0142nomocnictwo. Do umowy nale\u017cy do\u0142\u0105czy\u0107 pe\u0142nomocnictwo oraz/lub aktualny odpis z w\u0142a\u015bciwego rejestru, potwierdzaj\u0105cy umocowanie do dzia\u0142ania w imieniu Oferenta.\n\nW przypadku zawarcia umowy w formie tradycyjnej, Oferent zobowi\u0105zany jest przes\u0142a\u0107 dwa jednobrzmi\u0105ce egzemplarze podpisanej umowy na adres Beneficjenta: Zak\u0142ady Farmaceutyczne Polpharma SA Oddzia\u0142 Medana w Sieradzu, ul. Wojska Polskiego 73, 98-200 Sieradz .\nZa\u0142\u0105cznik nr 5 zostanie udost\u0119pniony na wskazany przez Oferenta adres e-mail w ci\u0105gu 2 dni roboczych od momentu otrzymania podpisanych orygina\u0142\u00f3w dokument\u00f3w. Nast\u0119pnie Zamawiaj\u0105cy zobowi\u0105zuje si\u0119 do podpisania i wys\u0142ania dw\u00f3ch egzemplarzy (po jednej dla ka\u017cdej ze Stron) umowy do Oferenta w ci\u0105gu 2 dni roboczych (termin podpisania i wys\u0142ania umowy przez Zamawiaj\u0105cego nie b\u0119dzie d\u0142u\u017cszy ni\u017c 2 dni robocze).\n\nPodpisan\u0105 umow\u0119 o zachowaniu poufno\u015bci nale\u017cy przes\u0142a\u0107 na adres e-mail: pawel.brzezinski@polpharma.com b\u0105d\u017a tradycyjnie nie p\u00f3\u017aniej ni\u017c na 4 dni robocze przed terminem sk\u0142adania ofert.\nDo umowy nale\u017cy za\u0142\u0105czy\u0107 pe\u0142nomocnictwo oraz/lub aktualny odpis z w\u0142a\u015bciwego rejestru, potwierdzaj\u0105cy upowa\u017cnienie do reprezentacji.\n \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.\nAttachment No. 5 will be made available by the Contracting Authority to the Bidder within 2 business days from the date of receipt of the confidentiality agreement signed by the Bidder with an electronic signature or with a traditional signature. The agreement must be completed and signed by a person authorized to represent the Bidder or holding an appropriate power of attorney. The agreement must be accompanied by a power of attorney and/or a current extract from the relevant register confirming the authorization to act on behalf of the Bidder.\nIn the event of concluding the agreement in a traditional form, the Bidder is obliged to send two identical copies of the signed agreement to the Beneficiary's address: Zak\u0142ady Farmaceutyczne Polpharma SA Oddzia\u0142 Medana in Sieradz, ul. Wojska Polskiego 73, 98-200 Sieradz.\nAttachment No. 5 will be made available to the e-mail address indicated by the Bidder within 2 business days from the receipt of the signed original documents. Then the Contracting Authority undertakes to sign and send two copies (one for each Party) of the agreement to the Bidder within 2 business days (the deadline for signing and sending the agreement by the Contracting Authority will not be longer than 2 business days).\nThe signed confidentiality agreement should be sent to the e-mail address: pawel.brzezinski@polpharma.com or traditionally no later than 4 business days before the deadline for submitting offers.\nA power of attorney and/or a current extract from the relevant register confirming the authorization to represent should be attached to the agreement.\n","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":"2025-04-24 14:04:09","modified_at":"2025-04-24 14:04:09","modified_by":null,"id":615632,"type":{"id":1,"name":"adres"},"group_uuid":"3e271870-d0cd-4f1b-ba4d-a9962e8c831c"}],"participation_conditions":[{"id":1522263,"description":"Oferent posiada wdro\u017cony i obowi\u0105zuj\u0105cy system zarz\u0105dzania jako\u015bci\u0105 w zakresie projektowania i produkcji wyrob\u00f3w medycznych potwierdzony certyfikatem ISO 13485 lub r\u00f3wnowa\u017cnym w zakresie zapewnienia zgodno\u015bci z wymaganiami dotycz\u0105cymi systemu zarz\u0105dzania jako\u015bci\u0105 dla wyrob\u00f3w medycznych, obejmuj\u0105cym m.in. zarz\u0105dzanie ryzykiem, nadz\u00f3r nad procesami produkcyjnymi, kontrol\u0119 jako\u015bci, zgodno\u015b\u0107 z przepisami prawa oraz mo\u017cliwo\u015b\u0107 \u015bledzenia partii produkcyjnych.\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 oraz do\u0142\u0105czy do oferty kopi\u0119 posiadanego certyfikatu.\n\nThe Bidder has an implemented and valid quality management system for the design and production of medical devices, confirmed by an ISO 13485 certificate or equivalent in terms of ensuring compliance with the requirements for a quality management system for medical devices, including risk management, supervision of production processes, quality control, compliance with legal regulations and the ability to trace production batches.\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 and will include a copy of the certificate with the offer.","type":{"id":1,"name":"Uprawnienia do wykonywania okre\u015blonej dzia\u0142alno\u015bci lub czynno\u015bci"},"created_by":null,"created_at":"2025-04-24 14:04:09","modified_at":"2025-04-24 14:04:09","modified_by":null,"group_uuid":"d04a2173-715f-4289-9845-65be70040ae5"},{"id":1522264,"description":"Oferent posiada co najmniej 3 letnie 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.\nOferent specjalizuje si\u0119 w rozwoju generycznych inhalator\u00f3w do zastosowa\u0144 w przemy\u015ble farmaceutycznym co najmniej 3 lata.\nOferent posiada 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\nThe Bidder has 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.\nThe Bidder specialize\u2019s in the development of generic inhalers for use in the pharmaceutical industry for at least 3 years.\nThe Bidder has 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":"2025-04-24 14:04:09","modified_at":"2025-04-24 14:04:09","modified_by":null,"group_uuid":"926f70bc-dd11-4e07-bba3-1e009febb460"},{"id":1522265,"description":"Oferent 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 lub r\u00f3wnowa\u017cn\u0105 w zakresie zapewnienia zgodno\u015bci z wymaganiami dotycz\u0105cymi systemu zarz\u0105dzania jako\u015bci\u0105 dla wyrob\u00f3w medycznych, obejmuj\u0105cym m.in. zarz\u0105dzanie ryzykiem, nadz\u00f3r nad procesami produkcyjnymi, kontrol\u0119 jako\u015bci, zgodno\u015b\u0107 z przepisami prawa oraz mo\u017cliwo\u015b\u0107 \u015bledzenia partii produkcyjnych.\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 kopi\u0119 certyfikatu ISO 13485 lub r\u00f3wnowa\u017cnego.\n\nThe Bidder has the ability to design and manufacture medical devices for administering inhaled drugs (inhalers) in accordance with ISO 13485 or equivalent in terms of ensuring compliance with the requirements for a quality management system for medical devices, including risk management, supervision of production processes, quality control, compliance with legal regulations and the ability to trace production batches.\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\u2019s a copy of the ISO 13485 certificate or equivalent.","type":{"id":3,"name":"Potencja\u0142 techniczny"},"created_by":null,"created_at":"2025-04-24 14:04:09","modified_at":"2025-04-24 14:04:09","modified_by":null,"group_uuid":"40229c9a-f116-40b7-a4a2-ab9028b61ab3"},{"id":1522266,"description":"Zamawiaj\u0105cy uzna, \u017ce Oferent spe\u0142nia niniejszy warunek, je\u017celi z\u0142o\u017cy o\u015bwiadczenie, \u017ce w chwili rozpocz\u0119cia prac dysponuje niezb\u0119dnymi zasobami ludzkimi do prawid\u0142owej realizacji zam\u00f3wienia. W\u015br\u00f3d kluczowych zasob\u00f3w powinni m.in. znale\u017a\u0107 si\u0119:\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\u015bwiadczenie 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. \n\nKa\u017cda z wy\u017cej wymienionych os\u00f3b powinna posiada\u0107 do\u015bwiadczenie w pracy z wyrobami medycznymi oraz posiada\u0107 znajomo\u015b\u0107 normy ISO 13485 lub r\u00f3wnowa\u017cnej w zakresie zapewnienia zgodno\u015bci z wymaganiami dotycz\u0105cymi systemu zarz\u0105dzania jako\u015bci\u0105 dla wyrob\u00f3w medycznych, obejmuj\u0105cym m.in. zarz\u0105dzanie ryzykiem, nadz\u00f3r nad procesami produkcyjnymi, kontrol\u0119 jako\u015bci, zgodno\u015b\u0107 z przepisami prawa oraz mo\u017cliwo\u015b\u0107 \u015bledzenia partii produkcyjnych.\n\n\nThe Contracting Authority will consider that the Bidder meets this condition if they submit a statement that at the beginning of the work, they have the necessary human resources 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\n\nEach of the above-mentioned persons should have experience in working with medical devices and have knowledge of the ISO 13485 standard or equivalent in terms of ensuring compliance with the requirements for a quality management system for medical devices, including risk management, supervision of production processes, quality control, compliance with legal regulations and the ability to trace production batches.","type":{"id":4,"name":"Osoby zdolne do wykonania zam\u00f3wienia"},"created_by":null,"created_at":"2025-04-24 14:04:09","modified_at":"2025-04-24 14:04:09","modified_by":null,"group_uuid":"648e82a1-3e09-4595-b61d-f95167a13103"},{"id":1522267,"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. 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