Licensor Requirements. In addition to the requirements set forth in this Mortgage, Debtor, in its ownership, use, occupancy and maintenance of the Mortgaged Property shall comply in all material respects with all requirements of its license agreement with Licensor. Debtor hereby consents to Mortgagee providing information it obtains to Licensor and to Mortgagee obtaining from Licensor information which Licensor receives relating to Debtor's operation of its business on the Premises.
Licensor Requirements. Limitations imposed by a third party licensor such as
1. Territory for manufacturing.
2. Limitations on quality control/regulatory activities as regards Earlier Stage Producer.
3. Limitations on information from Earlier Stage Producer. The following information shall be included concerning each Formulation, dosage form, dosage level and packaged stock keeping unit (SKU) covered by the Request for Bid. Additional information and requirements not inconsistent with this Agreement may be included at the discretion of the Partnership.
A. Packaging Information
1. Packaging specifications for the Packaging Manufacturing Stage, including without limitation the following:
(a) A narrative description for each product strength, size and finish and each quantity (per unit) and quantity per standard lot size.
(b) A brief summary of the manufacturing procedure.
(c) Manufacturing method (including in-process testing) describing in detail step-by-step the manufacturing procedure.
(d) Product specifications (tentative).
(e) Yield loss allowance, expressed as a decimal fraction.
(f) Packaging design and configuration specifications.
(g) Packaging material specifications.
2. Comments and descriptions regarding specific manufacturing and testing equipment - if any.
3. Testing Methods
(a) Finished product
(b) Finished Dosage Form
4. Safety, health and environmental issues information on any special safeguards to be used in production. Includes information such as toxicity data for eye contact, skin contact, inhalation and ingestion, dust explosion data and reactivity data. Special environmental considerations.
1. Quality assurance standards to be adhered to by the bidder, including inspection, audits, tests to be performed by the bidder and related documentation to be provided by the bidder.
2. Documentation to be maintained concerning quality control and related matters.
Licensor Requirements. Limitations imposed by a third party licensor such as
1. Territory for manufacturing.
2. Limitations on quality control/regulatory activities as regards Earlier Stage Producer.
3. Limitations on information from Earlier Stage Producer. A-12 79 EXHIBIT I PROCESS MANUAL FOR BULK CHEMICAL SYNTHESIS CONTENTS
A. CHEMISTRY AND PROCESS SUMMARY (For each step)
1. Reaction sequence with equations, structures, molecular weights and yield.
2. A table indicating material requirements (quantity and grade) on a common basis, i.e., so much intermediate and raw materials per kilo of drug product. Recoverable materials indicated by gross and net amounts.
3. A brief summary of the procedure with significant conditions.
4. Major waste streams with qualitative and quantitative data. Disposition of each stream.
5. Developmental studies in progress, if any, which could affect process.
B. PILOT OR FACTORY PROCESS (For each step)
1. Chemical Requirements - weight or volume, grade.
2. Equipment list indicating size, material of construction (acceptable alternatives), utility services to unit, agitation type and power, etc.
3. Flow diagram with material balances.
4. Operating Procedure - Operations listed in prose discussion with notes explaining:
a) Special points such as gas evolution, etc.
b) Allowable limits on variables, with consequences of exceeding. c) Heats of reactions, special heat transfer data.
Licensor Requirements
