CMC. Medgenics will be solely responsible for all chemistry, manufacturing and control activities for the Licensed Product to support Regulatory Approval for the initial indication in the Field in the Territory and the European Union, which, for clarity includes all CMC activities up to and including manufacturing process development, commercial scale-up and validation. Medgenics will bear all costs and expenses incurred in connection with the Manufacture of clinical supplies of Licensed Product for Development for the initial indication in the Field in the Territory and the European Union (including failed batches and any batches, or parts thereof, that are Manufactured after the Effective Date, in anticipation of clinical studies but which are not actually used), and disposal of clinical samples, and, for clarity, none of such costs will be included in Allowable Expenses. ***** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information.
CMC. Edison shall provide reasonable assistance to Penwest for Penwest’s preparation of the chemistry, manufacturing and controls (CMC) section of any IND filed or proposed to be filed by Penwest for a Specified Compound or Product, including requisite stability, pharmacology and/or toxicology data.
CMC. 5 years SCHEDULE – II PLASMA THAWING BATH1. TECHNICAL CHARACTERISTICS:1.1. Construction:• Table top with top opening having a deep thawing chamber with a stirrer and with water maintained at 37 ±1 deg C with pumping mechanism and inline heating system to ensure uniform thawing.• Quick thawing (<20min) should be able to thaw minimum of 6 plasma bags ofstandard 300 ml capacity (FFP/cryoprecipitate/Aphaeresis or plasma bags.• Tray with individual compartment to ensure that port of bags should be kept above water levels during the procedures.• Should give an alarm when the plasma bags are thawed.• Should have digital temperature display.• Should have audio visual over temperature alarm system.• Should have a system to drain the chamber easily.• Should be supplied with a cover to keep the unit covered when not in use.• Simple to use and easy to read LED display.• Drain line with shut-off valve.1.2. Tray: Removable type Stainless Steel trays with partitions for holding plasma bags.1.3. Capacity: minimum of 6 plasma bags of standard 300 ml capacity.1.4. Setting: Manual1.5. User’s interface: Manual2. Energy Source (electricity, UPS/battery, solar): 2.1. Power Requirements: Input voltage 220 /240V 50Hz single phase. 2.2. Other energy supplies: Suitable UPS with maintenance free batteries for minimum 30 mins backup should be supplied with the system.3. ACCESSORIES SPARE PARTS CONSUMABLES:3.1. Reusable wrap bag 500 numbers. 4. ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATION:4.1. Atmosphere/ Ambiance (Air-conditioning, Humidity, Dust):- Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%Capable of operating continuously in ambient temperature of 10 to 40 degree C and relative humidity of 15 to 90%4.2. Additional requirement: all equipment should specify design qualification operational qualification and performance qualification validation and calibration report should have traceability towards applicable National/International standards. Performance efficiency other factor such as distortion etc as applicable be also furnished. Complete construction details in respect material specification thickness finish etc are to be furnished.5. STANDARD AND SAFETY:5.1. Product Certification: CE; Should be supported with documentations or US FDA (The product must be enlisted under US FDA and the quoted model must have US FDA permission to market in US & export to other countries.5.2. Quality certifications: ISO certified5.3....
CMC. Neos shall, in consultation with Cornerstone’s development staff, prepare and provide regulatory data and documentation and draft CMC respecting the manufacture of [***] Confidential portions of the exhibit have been omitted and filed separately with the Securities and Exchange Commission. each Product, all in compliance with applicable Regulations. Cornerstone shall critically review and provide corrections to the CMC section in a timely fashion. Neos shall use commercially reasonable efforts to be prepared for any FDA pre-approval inspection of the Manufacturing Site. Neos shall cooperate with Cornerstone to respond to any FDA information requests relating to the CMC section that may arise during Federal or State Authorities Regulatory review and approval processes and, upon Cornerstone’s reasonable request, will provide other assistance related to obtaining marketing authorization for any Product. Cornerstone shall promptly ( but in no event later than ten (10) days following receipt or mailing or the discussion, as applicable) provide Neos with copies of all correspondence and summaries of all material conversations between Cornerstone and the FDA regarding each of the Products.
CMC. CMC shall indemnify, defend and hold harmless Customer and its affiliates, and each of its respective officers, directors, employees, agents, independent contractors, successors and assigns from and against liability for any third party claims based upon the CMC IaaS infringing or misappropriating any U.S. patent, copyright, or trademark of such third party. Notwithstanding the foregoing, in no event will CMC have any obligations or liability under this Section 16.2 arising from: (i) Customer’s use of CMC IaaS in a modified, unauthorized or unintended form; (ii) Customer’s violation of this Agreement; (iii) Customer’s use of the non-current versions of the CMC IaaS; or (iv) any Customer Content.16.3