BULK SOLUTION definition
Examples of BULK SOLUTION in a sentence
The parties agree that BC shall perform during DEVELOPMENT PHASE II and the commercial phase as per article 6 of the Agreement the lyophilization of the BULK SOLUTION to obtain BULK LYOPHILIZED BNP that meets the SPECIFICATIONS FOR BULK LYOPHILIZED BNP.
Based on the changes below to incorporate lyophilization into the manufacturing process to be performed by BC in DEVELOPMENT PHASE II and thereafter, the SPECIFICATIONS FOR BULK SOLUTION now have application primarily to the DEVELOPMENT PHASE I work.
Promptly following receipt of the BC DELIVERABLES, SCIOS NOVA shall determine whether it believes the samples and data indicate that BC will be able to meet the SPECIFICATIONS FOR BULK SOLUTION, and promptly advise BC of the results of its analysis.
The following references to BULK SOLUTION in the Agreement shall hereafter be deemed to be references to BULK LYOPHILIZED BNP: Whereas clauses 3, 5, & 6, articles 1.2, 1.3, 1.8, 1.15, 1.16, 1.21, 5.2, 5.5, 5.6, 6.3, 6.4, 6.5, 6.7, 6.8, 6.9 (all paragraphs), 7.1, 8.1, 8.2, 9.1, and 9.3.
In order to manufacture BULK SOLUTION in DEVELOPMENT PHASE II, BC will invest in planning, purchasing and installing of specific equipment, such activities and equipment to be listed in Annex 6 to this Agreement as investment.
The goal of the parties is to assess whether BC can produce BULK SOLUTION that meets the SPECIFICATIONS FOR BULK SOLUTION at a price equal to or less than the TARGET PRICE.
Subject to Article 6.9(e), (which applies after regulatory approval has been obtained), the price to SCIOS NOVA for BULK SOLUTION produced by BC after DEVELOPMENT PHASE II shall be the COMMERCIAL PRICE that the parties established under Article 5.5. Such price shall be valid until [*****].
As provided in Article 5.5, at the conclusion of DEVELOPMENT PHASE II the parties shall have established and documented by mutual agreement certain key matters, including, (a) the Standard Operating Procedure for the 3,000 liter PROCESS, (b) any revision to the SPECIFICATIONS FOR BULK SOLUTION, (c) any revision to the BNP SPECIFICATIONS, and (d) the COMMERCIAL PRICE.
In order that SCIOS NOVA is not dependent on a single supplier of BULK SOLUTION and recognizing that regulatory requirements dictate that all BULK SOLUTION utilized by SCIOS NOVA should be manufactured by the same process, BC agrees that beginning in 1998 and pursuant to Article 8.2, SCIOS NOVA may itself use, or have another supplier use, the 150 liter PROCESS or the 3,000 liter PROCESS to produce annually the quantity of BULK SOLUTION that is necessary to yield [*****] of BNP.
SCIOS NOVA may reject within [*****] after receipt of any batch of BULK SOLUTION that fails to meet the then current SPECIFICATIONS FOR BULK SOLUTION.