SMALL MOLECULE CONTRACT MANUFACTURING SERVICES

Submission of a Project Schedule Concept Requirement and Evaluation Bidders are requested to submit a detailed Project Schedule covering the following aspects: • time planning • work packages/tasks; major deliverables • regulatory support • client communication The concept will be evaluated according to the following criteria: • completeness and depth of detail • quality of the proposed measures • conformity with quality requirements and relevant regulations Formal requirements: minimum 5, maximum 30 pages (excluding table of contents and cover page) Time planning (30 points) 25 - 30 points Very good Conclusive, realistic and flexible planning with sensible milestones and buffer times. 17 - 24 points Satisfactory Basic scheduling with minor ambiguities or insufficient adaptability. 0 - 16 points Poor Unclear, unrealistic planning without buffer times and dependencies. Project structure & tasks (30 points) 25 - 30 points Very good Clear, logical distribution of tasks with sensibly linked deliverables. 17 - 24 points Satisfactory Basic structure in place, but with ambiguities in tasks or dependencies. 0 - 16 points Poor Illogical, incomplete task structure with missing deliverables. Regulatory support (20 points) 16-20 points Very good Support with IMPD writing (DS&DP sections) 8-15 points Satisfactory Support in answering regulatory questions (e.g. analytical methods) 0-7 points Poor Little to no support Client communication (20 points) 16 - 20 points Very good Clear reporting channels and communication structures with systematic documentation. 8 - 15 points Satisfactory Communication available, but not always clear or consistent. 0 - 7 points Poor Missing or inadequate communication structures and reporting channels. Overall rating (100 points) - Coherent and comprehensive concept that meets high standards. - Solid planning with optimization potential in individual areas. - Incomplete or impracticable concept with unfulfilled requirements. Quality evaluation The criterion "quality" is evaluated based on the following documents: B_02_Submission of a Project Schedule B_03_Submission of a manufacturing quality concept A maximum of 100 points can be achieved for the Project Schedule, representing a maximum of 35% of the quality score. Formula (quality per concept) = 35 * (bidder´s concept / 100)

Submission of a manufacturing quality concept Bidders are requested to submit a manufacturing quality concept covering the following aspects: • manufacturing track record (previous projects can be used as examples) • manufacturing sites, technical equipment and manufacturing processes • staff qualification and training • quality management measures The concept is evaluated according to the following criteria: • completeness and depth of detail • quality of the proposed measures • conformity with quality requirements and relevant regulations Formal requirements: minimum 4, maximum 10 pages (excluding table of contents and cover page) Evaluation scheme: manufacturing track record (25 points) 20 - 25 points Very good Coherent, detailed and methodical approach; successful production implementation proven through quality assured implementation. (Refer to projects already completed) 12 - 19 points Satisfactory Solid approach, but not consistently convincing; track record in manufacturing partly recognizable, but not specific enough. 0 - 11 points Poor Inadequate approach, vague description, no realistic implementation, no visible track record in manufacturing. manufacturing sites, technical equipment and manufacturing processes (25 points) 20 - 25 points Very good State-of-the-art technology, regularly maintained and innovative systems 12 - 19 points Satisfactory Solid equipment, functional and typical industry standard 0 - 11 points Poor Outdated or limited equipment, occasional failures Staff qualification and training (25 points) 20 - 25 points Very good Highly qualified and specialized staff with many years of experience 12 - 19 points Satisfactory Expert staff with solid training and relevant experience 0 - 11 points Poor Limited specialist knowledge or lack of experience in specific areas Quality management measures (25 points) 20 - 25 points Very good Convincing, consistent, modern quality management concept 12 - 19 points Satisfactory Quality concept available but incomplete 0 - 11 points Poor Not available. Overall rating (100 points) - Coherent and comprehensive concept that meets high standards. - Solid planning with optimization potential in individual areas. - Incomplete or impracticable concept with unfulfilled requirements. A maximum of 100 points can be achieved for the manufacturing quality concept, representing a maximum of 35% of the quality score. Formula (quality per concept) = 35 * (bidder´s concept / 100) *** Overall result The overall result is calculated from the composition of all points achieved for the individual award criteria. The contract will be awarded to the highest score bid.