CMOs. Notwithstanding anything to the contrary in this Supply Agreement, SutroVax shall have the rights to purchase Available Extracts and Extracts from CMOs (as defined in the License Agreement) to the extent provided in section 3.1 of the License Agreement.
CMOs. Each Party will be entitled to utilize the services of CMOs to perform Manufacturing activities under this Agreement, provided that: (a) such Party will require that each such CMO perform its obligations in a manner consistent with the terms of this Agreement; (b) such Party will remain at all times fully liable for its responsibilities; (c) in the case of Kymera, such CMO(s) (and specified manufacturing site(s)) shall be as set forth on Schedule 8.4 (as such schedule may be updated from time to time solely by prior written agreement of the Parties), provided that for [***], Kymera may continue to use its existing CMO; and (d) in the case of Sanofi, such CMO(s) will be selected in accordance with its internal standard operating procedures for the selection of CMOs. Each Party will require that any such CMO agreement entered into by such Party pursuant to this Section 8.4 entered into after the Original Agreement Execution Date [***]. The subcontracting Party will be solely responsible for direction of and communications with such CMO. In each CMO agreement entered into after the Original Agreement Execution Date that relates solely to Collaboration Compounds, Collaboration Candidates or Licensed Products, the subcontracting Party will use Commercially Reasonable Efforts to require that such agreement is freely assignable.
CMOs. Notwithstanding the provisions of Section 2.2 of this Agreement, Company shall establish processes related to the cell bank and drug substance processes as part of the Manufacturing Technology solely at a CMO. Company is recommended, but not required, to use [***] In the event that Company elects to use a CMO other than the aforementioned, Company shall be prohibited from establishing or transferring the Manufacturing Technology to any such CMO or geographical site except with the specific prior written approval of Novartis, in its sole discretion. Any contract with a CMO shall highlight the confidential nature of the Manufacturing Technology and the Antibody. If Company wishes to develop or generate its own cell line that does not use any Manufacturing Technology, Company may do so and may then use a CMO for its own cell line without requiring the prior consent of Novartis.
CMOs. Dynavax represents and warrants to Purchaser that (i) each Facility at which CpG Material is manufactured, tested, stored, packaged, labeled or supplied, is operated Confidential in compliance with Applicable Laws, including GMP and is registered with the applicable Regulatory Authority; and (ii) its agreements with its CMOs, including any quality or pharmacovigilance agreements, contain terms that are customary in biopharmaceutical industry and required to ensure that the CpG Material is manufactured, tested, stored, packaged, labeled, and supplied in compliance with Applicable Laws, including GMP.
CMOs. The reliable manufacture of high performance E(2)CMOS semiconductor wafers is a complicated and technically demanding process requiring: - a high degree of technical skill; - state-of-the-art equipment; - the absence of defects in the masks used to print circuits on a wafer; - the elimination of minute impurities and errors in each step of the fabrication process; and - effective cooperation between the wafer supplier and the circuit designer. As a result, our foundries may experience difficulties in achieving acceptable quality and yield levels when manufacturing our silicon wafers. WE MAY BE UNSUCCESSFUL IN DEFINING, DEVELOPING OR SELLING NEW PRODUCTS REQUIRED TO MAINTAIN OR EXPAND OUR BUSINESS As a semiconductor company, we operate in a dynamic environment marked by rapid product obsolescence. Our future success depends on our ability to introduce new or improved products that meet customer needs while achieving acceptable margins. If we fail to introduce these new products in a timely manner or these products fail to achieve market acceptance, our business and financial condition will be adversely affected. The introduction of new products in a dynamic market environment presents significant business challenges. Product development commitments and expenditures must be made well in advance of product sales. The success of a new product depends on accurate forecasts of long-term market demand and future technology developments. Our future revenue growth is dependent on market acceptance of our new proprietary ISP product families and the continued market acceptance of our proprietary software development tools. The success of these products is dependent on a variety of specific technical factors including: - successful product definition; - timely and efficient completion of product design; - timely and efficient implementation of wafer manufacturing and assembly processes; - product performance; and - the quality and reliability of the product. If, due to these or other factors, our new products do not achieve market acceptance, our business and financial condition will be adversely affected. OUR PRODUCTS MAY NOT BE COMPETITIVE IF WE ARE UNSUCCESSFUL IN MIGRATING OUR MANUFACTURING PROCESSES TO MORE ADVANCED TECHNOLOGIES In order to develop new products and maintain the competitiveness of existing products, we need to migrate to more advanced wafer manufacturing processes that utilize larger wafer sizes and smaller device geometries. We may also utilize ...
CMOs. Antifuse technology is non-erasable, non-reprogrammable and subject to lengthy initial programming times that can hinder usage in volume production applications. SRAM technology is volatile (erases when electrical power is removed), and as such programmable SRAM FPGAs require additional non-volatile memory, typically on a separate device, to store programming code. This adds cost and printed circuit board area to a design, and results in the devices not being completely functional at initial system power-up. PRODUCTS HIGH-DENSITY CPLDS SILICON. The Company first entered the high-density market in fiscal 1993 and currently offers four distinct families of ispLSI-Registered Trademark- products, each consisting of multiple devices. All devices are offered with ISP technology. The Company is currently shipping over 175 speed, package and temperature range combinations of high-density CPLDs. ISPLSI 1000: The Company's original high-density family utilizes an innovative, proprietary architecture incorporating familiar GAL-like logic building blocks. This family offers performance of up to 110 MHz, with propagation delays as low as 10 nanoseconds, densities of 2,000 to 8,000 gates, and is available in surface mount packages ranging from 44- to 128-pins. In fiscal 1996, the Company introduced the ispLSI 1000E family, an enhancement of the ispLSI 1000 family based on a more advanced sub-micron process technology. The ispLSI 1000E family offers enhanced performance of up to 125 MHz, with propagation delays as low as 7.5 nanoseconds.
CMOs. Denali may perform its obligations set forth under this Section 8.2 (Denali Supply Obligations) (the “Denali Manufacturing Activities”) itself or through a Third Party contract manufacturer (“CMO”) approved in writing by Biogen (which approval shall not be unreasonably withheld, conditioned, or delayed). Such approved CMOs are those CMOs set forth in Schedule 8.2.4 (Approved CMOs).
