Answers to the public call

13/05/20 - 16:04 ABEc

E-mail received on May 13th, about the proposal sent before the date of the public call." Dear Leadership Team, as you may remember we have already elaborated and sent our proposal for the complete conceptual and engineering design of all CPV vaccine processes for a fixed price. We have the experience and resources to produce the process designs required by your architect to design the CPV manufacturing facility. In addition, our manufacturing facility in Springfield, Missouri, USA, has the capacity and resources to manufacture all the six vaccine process lines simultaneously and for a fixed price. Our facility is the largest in the world dedicated to building biopharmaceutical manufacturing systems. When the world returns to normality there will be a great demand for biopharmaceutical equipment. We can manufacture all Butantan vaccine lines "under one roof". In conclusion we would like to thank you for inviting us to the public call the CPV reference project. However, we have reviewed the bidding documents on the CPV website and the documents seem to indicate that Butantan is no longer interested in ABEC systems, solutions and services as discussed in depth last year. Therefore, if this is the case, we wish you good health and success in your endeavors, regardless of resuming talks if our impression described above is wrong. In any case, we emphasize the need to maintain the confidentiality of ABEC proprietary data and information submitted to you, reiterating that Butantan is prohibited to use and share such data and information with any third party."

ABEC sent an e-mail to Fundação Butantan on May 13th, 2020, a date prior to the Public Call, which took effect on May 18th 2020. Even so, we understand that it would be important to add these questions to those made by the participants of the mentioned Public Call. Therefore, considering the manifestation of ABEC, we must emphasize that if it is of interest to the company a proposal for a conceptual and engineering project for all vaccine processes should be made and presented on the date  to be set on the Term of Reference and/or Public Notice for the assessment of proposals. As mentioned to the company in an in-person meeting, when they were accompanied by their Brazilian lawyers, the intention of Fundação Butantan is to hire a comprehensive solution. However, nothing prevents ABEC from presenting its proposal on the due upcoming opportunity.

 

18/05/20 - 14:20 Nordika

 

1. Is there a BID chronogram? What is the time schedule to prepare the proposal, etc? 

Fundação Butantan expects that the project is fully completed within the timeframe of a minimum of 36 and maximum of 40 months. However, further information regarding this aspect will be provide in the Term of Reference to be published soon.

2. How and when Butantan will perform Supplier Qualification? 

Supplier and their respective materials and services qualifications will be carried out by the Quality Assurance department of Fundação Butantan by means of analyzing requested documents and/or face-to-face audits. In addition, supplier selection criteria will be available on the website of Fundação Butantan when the Term of Reference and/or Public Notice is published.

3. Is there a preliminary draft regarding CPV or conceptual design already done?

Fundação Butantan has developed an internal conceptual project, however, it will be reviewed as there have been some changes made to its concept as, for example, regarding the location of the building and the number of facility floors/levels. As previously mentioned, the conceptual project guides towards what Fundação Butantan wants and both the basic and executive projects shall be elaborated by a national or international company or entity that presents a proposal for the solicited solution whether individually or in a consortium.

4. How Butantan is going to hire the turnkey? All suppliers are going to be hire since the beginning or in phases like first the design and after the construction?

Fundação Butantan intends to hire the company that presents the best solution for the technological commissioning. Initially, the aim is to hire the executive project and later, if the project is approved, to further the agreement aiming at the execution of the project. However, more information about this will be published in the Term of Reference.

5. Commissioning and qualification will be included in this contract? 

The contracted party will be responsible for the commissioning and qualifying of all areas and equipment. However, more information about this will be in the Term of Reference to be published soon.

6. What Butantan expect as the minimum time to delivery the CPV? 

Fundação Butantan expects the project to be fully completed within the minimum or maximum period of time of 36 to 40 months, respectively. However, as the intention is to hire a solution companies will submit proposals in which they will identify the deadlines. It should be mentioned that further information regarding this subject will be available in the Term of Reference to be published soon.

7. What Butantan intend to delivery CPV? Just the construction? After que qualification? Production running? 

The contracted party must deliver the CPV building fully commissioned and qualified. Fundação Butantan intends the contractual object be delivered ready-for-use, i.e., it expects a turnkey delivery. However, further information regarding this subject will be provided in the Term of Reference to be published soon.

 

18/05/20 - 16:30 Telstar

 

Good afternoon, in the "list of equipment for hepatitis A" there is only cover page of the document. Could you please upload the remainder of the document?

The equipment list for Hepatitis A was uploaded to the website on May 19th.

 

19/05/20 - 04:20 Samsung

 

1. Does Butantan have master schedule for this bid? We would like to know the expected time and period for each stage(PQ/BID/BD/EPCV etc.). 

Fundação Butantan intends that the contractual object be delivered fully commissioned, qualified and in operation within the minimum or maximum period of time of 36 to 40 months. Consequently, bidders must elaborate a schedule that meets this requirement. 

2. Do you plan to separate the bid for BD and EPCV? Or does this public call include the whole package from BD to EPCV? (We would like to know the detail scope of your planned bid.) 

The whole package will be hired from BD to EPCV.

3. Will there be extra period for PQ before BID? If there is, please let us know the expected time, period and evaluation criteria. 

There will be no pre-qualification period before the bidding process. Pre-qualification will occur during the bidding process by using technological commissioning.

4. What is the difference of evaluation criteria for Joint-venture company comparing with a single company participation in pre-qualification stage?

Evaluation criteria will be the same whether the applicant is a consortium or a single enterprise. These criteria will be objective and known to the interested bidders before the submission of the proposals. It is important to highlight that further information regarding this subject will be available in the Term of Reference to be published soon.

5. Is the proposal cost reimbursable? And what is the expected contract type for EPCV work? (Reimbursable, Cost+Fee, Lump sum) 

Costs arising from the mere participation of bidders in this Technological Commissioning will not be reimbursed.  As for the company winning the BID, compensation schemes shall be described in the Term of Reference - to be published soon.

6. What is the selection procedure for Engineering & Construction contractor? 

The proposal showing the highest probability of achieving the end result will be selected. The end result is understood as the construction of the building with the installation of the necessary equipment and process qualification. Therefore, aspects such as technical competence, management competence, price (considering economy and reasonableness) will be considered with other criteria to be published soon in Term of Reference.

7. Is the “FEED Competition” applicable for this project?

The winning company will be the company showing the highest probability in achieving the desired end result which, in this case, and in a summarized form is the construction of the CPV building. For this purpose, the evaluation will be made by means of a set of criteria such as technical competence of management, price, know-how, etc. However, accurate information regarding this subject will be in the Term of Reference to be published soon.

8. What is the project management consultancy (PMC) company for the whole project? 

A PCM company has not been hired yet. However, all the details and requirements for the hiring of the technological commissioning will be described in the Term of Reference. In addition, Fundação Butantan has elaborated an in-house conceptual project which will serve as a basis for the expected solution. It is important to mention that changes have been made to the initial project and they include changes to the location of the building and the number of facility floors/levels.

9. Is the value engineering (improvement) for CD required?

Value engineering is necessary since two main changes have been made to the concept of the building, one is regarding the location and the other the number of facility floors.

10. Is the deliverable list going to be provided to bidding companies within ITB, or do we have to prepare the BD BID with our own standard deliverable list? 

The documentation provided by Butantan indicates the minimum required but it is desirable that each company forwards its list of deliverables.

11. Are there extra requirements for GMP related documents for BD stage? 

Quality document requirements must meet FDA, EMA, WHO and ANVISA requirements.

12. Which is the necessary GMP approval? (ANVISA, US FDA, EU EMA, WHO) And does Butantan have special specification for biopharmaceutical plants other than the necessary GMP approval regulation? 

Approval from the FDA, EMA, ANVISA and WHO will be required. Regarding the biopharmaceutical facilities, Butantan has no further specifications that need to be met other than those already provided.

13. Do you consider the project experience of EPCV company regarding Vaccine facility of the whole Biologics facility? 

Yes

14. Does Butantan have all the technical data for 7 vaccines? If not, how many of them will come from technical transfer and how many companies will provide them?

Yes, Fundação Butantan has all the technical data for the seven vaccines.

 

19/05/20 - 21:00 CONTRACTA

 

1 - The project in question requires the grouping of several companies with expertise in specific areas in order to obtain a satisfactory final result with the consolidation of technical solutions that will allow the overcoming of technical difficulties specific to the project. How can the companies be grouped for participation, each one with its expertise in a specific area to obtain the final result? Can each grouped company, under the coordination of a main consortium, have its independent technical and financial responsibilites, that is, can there be a main consortium with 2 or more companies responsible for the contract, adding the expertise and technical qualifications of other companies that will work as subcontractors?

Interested companies may form a consortium and subcontract other companies to perform specific services provided the requirements described in the Public Notice and Annexe are met.

2 - Is it possible for bidders to, in addition to the technical and commercial proposal, make a proposal for partial financing for the implementation of some portions of the project that may be eligible for financing structures funded by national or international bodies?

Yes, the bidder can offer options for partial financing. In this case financing will be on behalf of Fundação Butantan.

 

20/05/20 - 10:04 NNE

 

Message: Rodrigo (NNE): "Hi, we are a Danish engineering company called NNE (former NNE Pharmaplan) and we heard that Instituto Butantan will have a great vaccine project. How can we participate in this bidding process of this project?"

The guidelines for taking part in the selection of suppliers whose object will be the construction of a vertical building that includes the installation of seven different and independent vaccine manufacturing plants can be found at http://cpv.butantan.gov.br/index

 

20/05/20 - 17:03 SIEMENS

 

1. Considering the scope of the project introduced, Siemens would like to query and gain clarification on the defining of equipment brands (including Siemens equipment). As noted, for example, the specifications for the main equipment of the HVAC (DEA-01018-PCO-AT-GE- MD-0001) includes software, panels and equipment from Rockwell who is a direct competitor of Siemens. There are also several other mentions of specific product codes implicating choice of specific brands. In other documents (e.g. DT-00000-NN-PR-VL-0001), a list of suppliers is presented, however, to be used as a reference.

Opting for the equipment brands and models described in the Descriptive Memorandum is not mandatory or required from bidders, they were mentioned as simple references.

2.In that sense and in view of the scope of the contracting, we hereby query whether a bidder should limit itself to the brands pre-established in the Descriptive Memorandum made available or if it may consider other brands and digital technologies in its offer (integrated Industry 4.0 concept). If the answer is positive, that is, if the bidder should limit itself to the pre-established brands and technologies, Siemens queries if the pre-establishing is technically justified in the scope of contracting the CPV innovation project.

Opting for the equipment brands and models described in the Descriptive Memorandum is not mandatory or required from bidders, they were mentioned as simple references. However, purchased equipment must meet all the norms and technical requirements of the project.

3. If the answer is negative, that is, the bidder may use other brands and digital technologies, including their own, and not those pre-established in the Descriptive Memorandum, even if the complete scpecifications documents as considered mere references (as suggested in the Public Notice under item 3.8), Siemens would like to ask if non-brand defining technical specification documents will be provided.

Opting for the equipment brands and models described in the Descriptive Memorandum is not mandatory or required from bidders, they were mentioned as simple references. In this way, the Descriptive Memorandum is to be considered impartial, since the brands and models mentioned there are only for reference.

4. Finally, Siemens would like to know whether Instituto Butantan will provide to all the parties interested in the project the assessments, legal opinions and non-statutory norms (e.g. guidelines, regulations, orders, etc.) used to prepare the proposal to hire by using the mechanism of Technological Commissioning.

The selection process of suppliers of Fundação Butantan is public and is available, except for any confidential documents, for consultation of the interested parties. Non-statutory norms (regulations and in-house policies) are available at (http://fundacaobutantan.org.br).

 

20/05/20 -20:45 PREMIER AUTOMATION

 

1.We wish to get more information on how to join this great project and would like to ask couple questions about AUTOMATION and SCADA solution:
Is there any mandatory standard regarding to Software and Hardware?
What is your ERP system on the current site?
Do you have any Pharma 4.0 concept already implemented?

SCADA solution manufactured by ELIPSE is used in the other manufacturing units of Instituto Butantan, however, for the current hiring it is not mandatory to use this solution. Finally, there is no Pharma 4.0 already implemented.

 

21/05/20 -11:58 Euromaxx

 

1.What is the forecasted schedule for the bid (publication of a public call notice, deadline for the elaboration of proposals, analysis of proposals, hiring, among others)?

The project schedule, description of project stages, evaluation criteria for the stages ad deadlines will be available in the Public Notice/Term of Reference.

2. "General Questions: 

1) Considering this is a technological commissioning, what are the expected aspects of technological innovation? 

2)Could you please clarify the object/scope of hiring and the respective hiring models? 

3)Have the objective criteria for the analysis of proposals been defined? "

1) The most innovative feature of this project is the possibility of manufacturing seven specific types of vaccines, involving several types of microorganisms, in a single building, which will allow the full operation of the manufacturing areas in a totally independent way.
2) That information is expressly provided in the Public Notice and in the additional documentation provided.
3) The evaluation criteria of the stages and deadlines will be made available in the Public Notice/Term of Reference.

 

3.Civil Discipline Questions:
1) Are there any structures in the area destined for the complex that must be demolished?
Is it an area listed as historical heritage?
Does it being a historical heritage area affect in any way the required demolition or the implementation of the project?
2) Should the existing IB building standards be reproduced? (Building Structures, Side Closures, Roofing, Pipe Racks etc.)
3) When it reads that “utilization of resources that provide energy efficiency and lower environmental impacts” are sought, what systems are being referred to?

Regarding the first question, there are no structures to be demolished. On your second point, please be informed that building standards must be reproduced, modules and frontage as established in the Master Plan. Finally, relating to the last question, among the systems referred to are the utilization of steam condensate, reuse water (grey water), etc.

4. "About financing: Will the debtor be the Institute itself?
What is the desired funding period? Are there any resources already allocated in any bank? Will there be any guarantee from the government of the state of São Paulo?"

The desired deadline for the financing will be evaluated according to feasibility study and proposed amount to be invested. At this point, there is no funding allocated for the project under the management of a bank. There is no assurance from the Government of the state of São Paulo. Fundação Butantan will be the garantor.

 

21/05/20 - 12:57 Teixeira Duarte

 

1. "As explained on public call video the mechanism of technological commissionin is unprecedented in Brazil, consists in seeking a solution for a need presented by the contractor, however, when analyzing the documentation provided on the website such as the Descriptive Memorandum and conceptual projects, it becomes clear that solutions already exist for the 7 vaccines, which will be implemented on two manufacturing floors. Our question is regarding the last floor since it has not been made evident what is the requirement for it by the end user. Will the directive and/or need for use of this floor be presented in public notice?"

Firstly, it is important to clarify the technological risk involved in this type of contract. The most innovative feature of this project is the possibility of manufacturing seven specific types of vaccines involving several types of microorganisms in a single building, which will allow the full operation of the manufacturing areas in a totally independent way. Regarding the use of several floors/levels, Butantan has elaborated an in-house conceptual project which can/should be reviewed by the contracted company considering the concept of the project has been changed twice after it was elaborated and two major changes have been made. The first change concerns the location of the building and the second the number of manufacturing floors/levels. This information was provided in detail in the "EPC TURNKEY PROJECT ENGAGEMENT DESCRIPTIVE MEMORANDUM" document.

2. Will a macro schedule with the bidding stages be presented, such as the deadline for presentation of Fundação Butantan needs, R&D presentation and validation and pricing of proposals?

All the steps and rules for the selection and hiring procedure will be described in the Public Notice/Term of Reference and its Annexes.

3. Will the manufacturing capacity (demand) for each vaccine be defined in a public notice?

The manufacturing capacity for each vaccine will not be established in a Public Notice. An estimate of the manufacturing capacity calculated by Butantan will only be provided to the winning company.

4. How will cost estimating for materials of common use be carried out? Considering building materials which do not depend entirely on the technological solution to be presented and may have varying quantities according to the needs of the Contractor as, for example, in the case of clean room panels which may have quantities changed according to the layout required.

Materials and the quantities of materials should be provided in the Basic Design project by the company contracted. Applicable norms and data required will be provided in the Term of Reference. 

5. Will equipment existing at Fundação Butantan be reutilized? The question refers to Item 7.2.1(DT-01018-PC-PR-MD-0002) on page 15 where this probable need is not clear.

There are few equipment at Fundação Butantan which have been planned for use in this project. However, among the planned equipment, the hired company is responsible for evaluating the possibility or not of using these equipment in the CPV project.

6.Will the rules of FD be established in the public notice?

Direct billing will be considered under the terms of the applicable legislation and if the possibility exists it will be established in the Term of Reference.

7. The stated volumetry conceptual project (DI-01018-EP-AR-DE-1010_03) indicates that the CPV construction site is different from the one proposed in the Descriptive Memorandum and Conceptual Project (01018-000-EP-AR-DE-0001_00 PROPOSTA IMPLANTACAO). Which site should be considered? The question is made due to the fact that the conceptual project of volumetry is positioned over existing constructions.

Regarding the location for the construction of the CPV building please consider the information provided in the Descriptive Memorandum nº DI-01018-EP-AR-MD-001_03, page 6, item 2.1. Finally, the DI-01018-EP-AR-DE-1010_03 document was developed as a volumetric analysis, that is, the preliminary height of the building.

8. We did not find in the documents provided layouts for annexe support buildings, will these be presented by Instituto Butantan as conceptual projects or will they be fully elaborated by the Contractor?

The documents in question will be elaborated by the contracted party (bid winner).

9.Will documents such as soil surveys be presented in public notice?

Soil surveys will not be presented; it will be responsibility of the contracted party.

10. Should all environments contain displays in the production area? Standard design dimensions for where there are no interferences have not been informed. 

The contracted party will be responsible for positioning all the displays, technical panels and other necessary items during the development of the project, according to item 3.6.2 of the Descriptive Memorandum DI-01018-EP-AR-MD-001_03, page 14.

11. The Architecture specifications document (DI-01018-EP-AR-MD-0001) mentions the document for project DEA-0040-PBAR-DE-1400_00 on page 68, however, this document has not been provided. Will it be provided in the next stages of the contracting process?

The sentence in the paragraph reads: "The CONTRACTED PARTY shall consider the execution of the floors of these areas, as indicated in the Finishing Plant (DEA-00040-PB-AR-DE-1400_00), of document DI-01018-EP-AR-MD-001_03, page 68, which refers to a finishing plant, which shall be developed by the contracted party. Therefore, disregard the mention.

12. We have not found in the document provided any areas for R&D activities. Will the CPV building have any areas dedicated to R&D activities, such as auditoriums or specific rooms for research?

Areas dedicated to R&D activities will not be established in the building which is the object of this technological commissioning. The project refers to the manufacturing of Active Pharmaceutical Ingredients (APIs).

13. We were unable to find the the documentation provided any reference made to how the licensing processes of the industrial units will be dealt with. Will industrial unit licensing processing in addition to design, installation and operation qualifications be a scope of the hired party or will it be performed by external companies?

The contracted party (winning company) will be responsible for the commissioning and qualification of areas and equipment. However, as described in the procedure is possible to subcontract the activity provided all predefined quality requirements are met.

 

22/05/2020 RADIX Engenharia e Software

 

1. "Our company has some questions. It is clear on the website, video and PUBLIC CALL NOTICE document N.º 001/2020 that the proposal is of a Technological Commissioning which is a challenging and innovative process that, as disclosed, will use a series of changes in the legislation to expedite processes make them less bureaucratic and hampered (for example law 8666).However, the document ""EPC TURNKEY PROJECT ENGAGEMENT DESCRIPTIVE MEMORANDUM, BUILDING 1018 - CPV VACCINE PRODUCTION CENTER"", chapter 12, seems to deal with conventional EPC hiring.Please find some example items and our comments:

-General list of drawings and documents of the project divided by discipline MUST BE DESCRIBED IN A1 Equivalent, in order for us to be able to technically equalize bidders;

Technological Commissining solutions are not hired using man-hours or equivalent A1, this is an outdated practice.

- Permanent workers foreseen for the execution of the project classified as engineers, architects, designers, coordinators, managers, etc;

Classification depends on the engineering project and the solutions established, for example, if during the execution of the project there is the need to hire a new specialist, our company will do so to for the successful delivery of the Technological Commissioning solution.

- Permanent workers foreseen for the execution of the assembly classified as engineers, technicians, officers, assemblers, etc.;

Classification depends on the engineering project: basic design and executive design which depends on all the decisions and routes defined, such as the construction plan adopted (constructability studies)

 Quantitative spreadsheet of materials and services.

 It depends on the executive project, which depends on the basic engineering, which depends on the innovative solutions designed/established for each process unit, among others.

 Our question is: Will the document EPC TURNKEY PROJECT ENGAGEMENT DESCRIPTIVE MEMORANDUM, BUILDING 1018 - CPV VACCINE PRODUCTION CENTER be revised, especially regarding the comments made above?

The mentioned items are necessary for us to evaluate (as contracting party) whether the company will be able to achieve its own technological solution, in the amount of number of documents that will be issued in the project design stage and number of strategic professionals (managers, coordinators, engineers) who will work in the various disciplines in the design and construction stages.                                                                                                                                                                                                                  The number of documents or number of personnel will not be definite numbers, neither will they be exact for the elaboration of the project design and construction, but knowing those number we will be able to evaluate if there will be the minimum required for each solution presented.