Serial Production Clause Samples

Serial Production. 7.1 Identification & traceability

Serial Production. 5.1 For the term hereof, BIOSITE shall purchase all Fl-Meters it requires exclusively from LRE, and LRE shall have the exclusive right and obligation to produce all Fl-Meters required by BIOSITE, except (i) if LRE is not capable to produce sufficient quantity of Fl-Meters to satisfy BIOSITE's needs, or (ii) with respect to any specific immunoassay application which BIOSITE requests, if LRE is prohibited from producing Fl-Meters for BIOSITE for such immunoassay application. 5.2 Each Fl-Meter shall be manufactured in accordance with the Specifications. The Specifications may be modified from time to time only by written approval of both parties. 5.3 In order to appropriately prepare for the necessary production volumes LRE needs firm orders for the [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] prior to the beginning of the first [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] of production and an update each subsequent quarter (revolving forecast) for the following [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION]. BIOSITE shall place its orders and forecasts, and shall purchase Fl-Meters, as follows: BIOSITE shall purchase a specified quantity of Fl-Meters specified in each order and forecast as follows: BIOSITE shall purchase in the [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] all Fl-Meters firmly ordered for the [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] according to BIOSITE's binding order. BIOSITE shall purchase in the [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] at least [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] of the quantity ordered for the [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION]. The remaining [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] of the quantity firmly ordered for the [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] may be accepted by BIOSITE alteratively in the [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] following the order and forecast. The forecast for the [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] following the order and forecast shall not be binding on BIOSITE. BIOSITE shall be obligated to reimburse LRE for the costs of materials purchased for that quantity of Fl-Meters forecast for the [CONFI...

Serial Production. SUPPLIER is obliged to take random samples regularly during production and to document the results and to make the results available to BÄR upon request. Process parameters that may negatively influence product characteristics must also be taken into account accordingly. Process interruptions (e.g. tool breakage) and quality control measures must be clearly traceable from the records. For the release of a production lot, no defective product may be found in the random sample as a matter of principle. If a defect is found in the product during the manufacturing process, the SUPPLIER must immediately interrupt the process and correct it. In this case, all products that have been manufactured since the last sample inspection (last good part) carried out with a positive result must be inspected 100%. Defective products must be secured immediately and stored in a separately marked location (restricted storage) until the cause of the defect has been finally clarified. Corrective measures initiated must be documented in the records in a traceable manner. If a rework inspection shows that the defective products cannot be reworked, they must be scrapped. In the event of rework, all specified serial inspections are to be carried out. If, in exceptional cases, the SUPPLIER cannot deliver products that comply with the specifications, it must obtain a special release from BÄR prior to delivery.

Serial Production. The Supplier shall be responsible for the use of effective systems for the monitoring of process and product quality. All amendments to parts or to the production process shall be documented by the Supplier in the maintenance history. The Supplier shall compile inspection plans and inspection instructions for all necessary inspections (receiving inspections, intermediate inspections, final inspections and special inspections) based on AQL accepted ISIR \ PPAP. With regard to content the inspection plans must be arranged in such a way that all defects that come into consideration can be found using the current best available technology.

Serial Production. 5.1 For the term hereof, BIOSITE shall purchase all Fl-Meters it requires exclusively from LRE, and LRE shall have the exclusive right and obligation to produce all Fl-Meters required by BIOSITE, except (i) if LRE is not capable to produce sufficient quantity of Fl-Meters to satisfy BIOSITE's needs, or (ii) with respect to any specific immunoassay application which BIOSITE requests, if LRE is prohibited from producing Fl-Meters for BIOSITE for such immunoassay application. 5.2 Each Fl-Meter shall be manufactured in accordance with the Specifications. The Specifications may be modified from time to time only by written approval of both parties. 5.3 In order to appropriately prepare for the necessary production volumes LRE needs firm orders for the first 2 quarters prior to the beginning of the first full year of production and an update each subsequent quarter (revolving forecast) for the following 4 quarters. BIOSITE shall place its orders and forecasts, and shall purchase Fl-Meters, as follows: BIOSITE shall purchase a specified quantity of Fl-Meters specified in each order and forecast as follows: BIOSITE shall purchase in the first quarter all Fl-Meters firmly ordered for the first quarter according to BIOSITE's binding order. BIOSITE shall purchase in the 2nd quarter at least two-thirds of the quantity ordered for the 2nd quarter. The remaining one-third of the quantity firmly ordered for the 2nd quarter may be accepted by BIOSITE alternatively in the third or fourth quarter following the order and forecast. The forecast for the 3rd quarter and not purchased in the 3rd or 4th quarter following the order and forecast shall not be binding on BIOSITE. BIOSITE shall be obligated to reimburse LRE for the costs of materials purchased for that quantity of Fl-Meters forecast for the 3rd quarter and not purchased in the Each firm purchase order shall provide delivery dates and delivery information requirements. 5.4 If serial production is not possible for whatever reason--unless BIOSITE terminated this agreement under paragraph 10.2 (c) or 10.3--or if BIOSITE fails to order and purchase 500 F1-Meters during the first twelve (12) months of production, BIOSITE shall reimburse LRE for that portion of the cost for the specific tooling purchased by LRE for the Fl-Meter specific production equipment that was not reimbursed through the pricing structure for the first twelve (12) months of production. 5.5 Delivery by LRE shall be made at least quarterly. LRE shall deli...

Serial Production complaints

Serial Production