8.2.3. Each party undertakes to provide the other party with all manufacturing, testing or storage data within 48 hours, if necessary due to administrative control or possible regulatory exposure, such as a recall or a major product claim. The Company reserves the right to defer, reduce or cancel the delivery of goods ordered by the Customer (without liability to the Customer) if it is prevented or delayed in the performance of its activities due to circumstances beyond its proper control. including the actions of God, Local acts or authorities, acts, restrictions, regulations, statutes, prohibitions or measures of any kind, war, sabotage, insurrection, agitation or national state of emergency, acts of terrorism, protests, riots, disturbances, fires, explosions, epidemics, accidents, imports or exports or embargoes, restrictions or delays affecting carriers, any incapacity or delay in the supply of appropriate equipment. The terms of the agreement vary according to the needs of the parties. For example, Company A may enter into a strategic marketing agreement with Company B, requiring Company B to enter into clinical trials and regulatory applications for the marketing of a product abroad, and requireA A to make all devices available at an agreed price for royalties (cf. B Neoprobe Corp., Securities and Exchange Commission (SEC) 10-K-Einreichung, Commission File 0-26520, March 31, 1998). On the other hand, a manufacturing agreement cannot require Company B to manufacture one or more of its devices and to deliver it to Company A. 1.1.2. The agreement also defines how BAXTER Quality Operations and IDEC Quality Department interact with each other. 1.21 “Master Batch Record” refers to the formal set of instructions for the manufacture of each kit or kit component. The Master Batch Record for the production of the 2B8-MX-DTPA conjugate antibody bottle is available at Appendix 4.
The Master Batch Record for the other kit component is the formal set of 1.21 instructions for the manufacture of such a kit component which is acceptable to the parties for both parties and which contains (unless the parties otherwise agree in writing) all the contents of the lot data set that client BAXTER has previously made available for this kit component. The parties make reasonable economic efforts to finalize the master batch record for the other kit component within twenty-one (21) calendar days following the validity date (but at least before the preparation of a stability/validation batch for a kit component). The Master Batch Record for the other kit component is added to Schedule 4 after the end of the reclamation period.