Process Development Programs Sample Clauses

Process Development Programs. (a) The Development Management Committee shall decide which process technologies—e.g., hybridoma, recombinant, Cell: Cell Fusion—shall be used in the Process Development Program for each lead Research Antibody and Candidate Drug. AZ shall have the sole right to make decisions regarding (x) the use of any Third Party royalty bearing technology Controlled by ABX, and the in-licensing of Third Party intellectual property in connection with the use of technologies that are not already Controlled by ABX or that are specific to such Research Antibody and Candidate Drug, and (y) without limiting the obligation of AZ to purchase (and ABX to supply) AZ’s requirements of each of its Research Antibodies and Candidate Drugs from ABX as provided herein [Confidential treatment requested], the need for any backup facility, and selection, qualification and use of any Third Party manufacturing facility for each such Research Antibody and Candidate Drug. The Parties acknowledge and agree that (i) the decision to commence a Process Development Program should take into consideration the likelihood that an Antibody will be designated a Candidate Drug, (ii) it may be necessary or useful to simultaneously pursue the development of multiple process technologies for a particular Candidate Drug based on scientific, technical, intellectual property or commercial considerations, (iii) the process technology used to manufacture early clinical supplies of a Candidate Drug may be different than the process technology used to manufacture later stage clinical and commercial supplies of such Candidate Drug or the applicable Licensed Product, (iv) the Parties intend that the process technology and the facility (or facilities) to be used to manufacture a Licensed Product for Phase III Clinical Trials will be the same as that used for commercial supply, (v) the Process Development and Manufacturing Plan for each Licensed Product will include reasonable plans for fully-qualified back-up manufacturing facilities to provide for uninterrupted supply upon the occurrence of a Force Majeure event or increased product requirements beyond the quantities that ABX is able to supply, and (vi) the Process Development and Manufacturing Plan for each Licensed Product will include a plan for technology transfer to AZ (or its designee) in accordance with Section 7.10.
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Process Development Programs 
Sample 1

Related to Process Development Programs

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • Research and Development (i) Advice and assistance in relation to research and development of Party B;

  • Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Collaboration Management Promptly after the Effective Date, each Party will appoint a person who will oversee day-to-day contact between the Parties for all matters related to the management of the Collaboration Activities in between meetings of the JSC and will have such other responsibilities as the Parties may agree in writing after the Effective Date. One person will be designated by Merck (the “Merck Program Director”) and one person will be designated by Moderna (the “Moderna Program Director,”) together will be the “Program Directors”. Each Party may replace its Program Director at any time by notice in writing to the other Party. Any Program Director may designate a substitute to temporarily perform the functions of that Program Director by written notice to the other Party. The initial Program Directors will be: For Moderna: [***] For Merck: [***]

  • Business Development Provide advice and assistance in business growth and development of Party B. 业务发展。对乙方的业务发展提供建议和协助。

  • Regulatory Affairs Each Party shall advise the other Party of any regulatory action of which it is aware which would affect the Product in any country of the Territory.

  • Research Neither the Investor nor any Affiliate of the Investor shall have, in the prior thirty (30) days, published or distributed any research report (as such term is defined in Rule 500 of Regulation AC) concerning the Company.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

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