Romania – Medicinal products for the alimentary tract and metabolism – SEBELIPASE ALFA

**Procurement of Sebelipase Alfa - According to the Terms of Reference**

**Number of days within which clarifications can be requested before the deadline for submission of tenders/applications: 6 days**

**Deadline within which the contracting authority will respond to clarification requests in a clear and complete manner: 4 days before the deadline set for the submission of tenders to participate.**

**Subsequent contracts will be awarded monthly, quarterly, or semi-annually, depending on the availability of budget funds and the needs of the contracting authority.**

**Minimum and maximum quantities that may be the subject of the framework agreement:**

* **Sebelipase Alfa - minimum 6 CUT - maximum 350 CUT X 1FL.**

**Clarification requests will be submitted ONLY through the SICAP; Responses to clarification requests will be submitted ONLY through the SICAP.**

**The contracting authority reserves the right to make changes to the framework agreement, as follows:**

**The framework agreement and the subsequent contracts may be modified by additional acts in the following situations:**

**The maximum quantities that can be supplemented up to 10% of the quantities related to the framework agreement, in accordance with the provisions of art. 221 lit. f) of Law 98/2016 on public procurement, with subsequent amendments and additions, corroborated with those of art. 6 of Instruction 3/2017, are considered a non-substantial modification – value threshold.**

**Any modification of the contact details, authorized representatives of the Parties, contact persons, bank accounts and banks through which payments are made**

**The rights and obligations of the supplier, established through this Framework Agreement, are assumed by another economic operator as a result of a universal succession or by universal title within a reorganization process, under the conditions established by law.**

**Identification of any errors, omissions, or any vices in the requirements of the Purchaser, specified in the present Award Documentation**

**Identification of the need for any reduction/increase/modification of the Framework Agreement or any part of it (example: ensuring the storage of Products for a certain period or for a longer period, issuing orders with partial quantities, issuing orders in longer or shorter terms).**