Manufacturing Capabilities. Supplier will have the manufacturing and shipping capability to make enough units of the Product covered by this Agreement for Distributor to reach its sales obligations.
Manufacturing Capabilities. Supplier warrants that it has the manufacturing and shipping capability to make enough units of the Product covered by this Agreement to satisfy the minimum distribution requirements under this Agreement. Further, Supplier will use all commercially reasonable means to fulfill any demands in excess of the minimum distribution requirements.
Manufacturing Capabilities. Pursuant to the POC Plan for a given Program [***], Moderna will [***] to establish [***] for use as part of such POC Plan (and the Development Plans, if applicable) for such Program, which will include [***], in accordance with the Development Plans (or POC Plans, if applicable) and this Agreement. [***]
Manufacturing Capabilities. BIP shall at all relevant times throughout the Supply Term (a) own or lawfully control all the necessary plant, equipment and facilities and (b) have sufficient numbers of appropriately qualified personnel, in each case to enable BIP to manufacture Bulk Drug Substance, Drug Product and Finished Product in accordance with the Specifications and in quantities sufficient to fulfill the Firm Orders made within the Maximum Request under this Agreement.
Manufacturing Capabilities. Genentech shall at all relevant times -------------------------- throughout the Term use Commercially Reasonable Efforts consistent with the terms of this Agreement to (a) own or lawfully control all the necessary plant, equipment and facilities, and (b) have sufficient numbers of appropriately qualified personnel, in each case to enable Genentech to manufacture Bulk Drug in accordance with the Bulk Drug Specifications and in quantities sufficient to fulfill its obligations to supply Bulk Drug under this Agreement.
Manufacturing Capabilities. Lonza shall at all relevant times throughout the Term use Commercially Reasonable Best Efforts consistent with the terms of this Agreement to (a) own or lawfully control all the necessary plant, equipment and facilities, and (b) have sufficient numbers of appropriately qualified personnel, in each case to enable Lonza to manufacture Bulk Drug in accordance with the Bulk Drug Specifications and in quantities sufficient to fulfill its obligations to supply Bulk Drug under this Agreement.
Manufacturing Capabilities. Olympus (or a third party acting on behalf of Olympus) shall be responsible for acquiring and/or developing all necessary Final Product(s) manufacturing capabilities, including equipment and facilities, as provided in the Development Plan.
Manufacturing Capabilities. Wyeth or one or more of its Affiliates (or its or their successors upon sale of the Facility) shall, at all relevant times throughout the Term, own or lawfully control the Facility. Wyeth or one or more of its Affiliates shall use its Commercially Reasonable Efforts to staff the Facility with sufficient numbers of appropriately qualified managers, supervisors, engineers, technicians, inspectors, and other personnel, all of whom have reasonable and sufficient technical expertise, in each case to enable Wyeth to manufacture Product in accordance with the Product Specifications and to fulfill its obligations under this Agreement.
Manufacturing Capabilities. Aerojet believes it remains competitive in its markets. Raw materials required by this segment are generally in adequate supply. Backlog in Aerojet's businesses is significant. Aerojet's contract backlog was approximately $1.3 billion at November 30, 2000, compared to $1.6 billion at November 30, 1999. Funded backlog, which includes only the amount of those contracts for which money has been authorized by Congress, totaled approximately $0.7 billion at November 30, 2000, unchanged from November 30, 1999. VEHICLE SEALING Revenues from the Company's automotive Vehicle Sealing business are principally derived from the development, manufacture and sale of highly engineered extruded and molded rubber products for vehicle bodies and window sealing for the original equipment automotive market. These products are designed to prevent air, moisture and noise from penetrating vehicle windows, doors and other openings. As previously described, the Company completed in December 2000 the acquisition of the Draftex International Car Body Seals Division of The Xxxxx Group Public Limited Company (the Draftex business or Draftex). The Draftex business is now part of the Vehicle Sealing segment. Together, the GenCorp and Draftex vehicle sealing businesses, now known as GDX Automotive, provide a substantially broadened and more diversified customer base. The Vehicle Sealing segment will become the world's second largest automotive sealing supplier and the largest North American supplier of highly engineered vehicle sealing systems. North American operations primarily produce extruded rubber profiles consisting of a roll-formed steel wire or steel frame surrounded by extruded rubber which is cured, cut and molded to meet customer specifications. This business supplies products to the North American automotive assemblers for use in a wide variety of vehicles including Ford F-Series and Ranger pickups, Ford Explorer; the General Motors C/K pickup and Grand Am, Saturn Z and LS, Honda Accord and the DaimlerChrysler All Purpose Vehicle. The European-based Henniges operations design and produce vehicle sealing systems, encapsulated glass and molded rubber parts, specializing in products which dampen and isolate vibrations, reduce noise and generally seal automotive components. This business unit supplies components to major European automotive original equipment manufacturers, including Volkswagen/Audi, Opel, BMW and DaimlerChrysler. The newly-acquired Draftex operations produce ext...
Manufacturing Capabilities. If Forte or any of its third-party manufacturers encounter difficulties in manufacturing its product candidate, its ability to provide supply of its product candidate for clinical trials or its products for patients, if approved, could be delayed or stopped, or Forte may be unable to maintain a commercially viable cost structure. The manufacturing process used to produce Forte’s product candidate is complex and novel, and it has not yet been validated for investigational and commercial production. As a result of these complexities, the cost to manufacture Forte’s product candidate is higher than traditional small molecule chemical compounds and the manufacturing process is less reliable and is more difficult to reproduce. Furthermore, its cGMP manufacturing process development and scale-up is at an early stage. The actual cost to manufacture and process its product candidate could be greater than Forte expects and could materially and adversely affect the commercial viability of its product candidate. Forte’s manufacturing process may be susceptible to manufacturing issues associated with interruptions in the manufacturing process, contamination, equipment or reagent failure, improper installation or operation of equipment, vendor or operator error, and variability in product characteristics. Even minor deviations from normal manufacturing processes could result in reduced production yields, lot failures, product defects, product recalls, product liability claims and other supply disruptions. If microbial, viral or other contaminations are discovered in Forte’s product candidate or in the manufacturing facilities in which its product candidate are made, production at such manufacturing facilities may be interrupted for an extended period of time to investigate and remedy the contamination. Further, as product candidate are developed through preclinical to late-stage clinical trials toward approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives, and any of these changes could cause its product candidate to perform differently and affect the results of planned clinical trials or other future clinical trials. Further, changes made to its manufacturing process will require prior approval by FDA, which can delay Forte’s clinical trials and r...
