Licensed Manufacturing Know-How definition

Licensed Manufacturing Know-How has the meaning set forth in Section 6.4 (Manufacturing Technology Transfer).

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Licensed Manufacturing Know-How means all proprietary manufacturing process-related Know-How directly relating to the manufacture of the Licensed Lead Antibody Compound that both (i) is Controlled by AMGEN or its Affiliates and (ii) [***], in each case (i) and (ii) prior to the Effective Date, as set forth on Exhibit A; provided, however, that “Licensed Manufacturing Know-How” excludes (1) any Know-How relating to AMGEN’s or its Affiliates commercial manufacturing platform and (2) any Know-How solely relating to the research, development or manufacture of [***].

Licensed Manufacturing Know-How means the Know-How Controlled by UCB as of the Effective Date *** in the manufacture of the Compound and Licensed Product under the current manufacturing process. The Licensed Manufacturing Know-How existing on the Effective Date is listed in Schedule 5.

Examples of Licensed Manufacturing Know-How in a sentence

In the event that it is alleged that the Sublicensee relied on the Licensed Manufacturing Know-How in breach of its obligations under this Sublicense Agreement or for purposes not contemplated in this Sublicense Agreement, the defenses set out in Section 10.1(b) will be available to the Sublicensee.
Following the expiration of such licenses in the Territory, the licenses granted in Section 2.1 with respect to Licensed Manufacturing Know-How will be fully paid-up and perpetual.
MPP will not have any right to practice the license granted under this Section 2.1 or otherwise exploit the Licensed Patent Rights and Licensed Manufacturing Know-How for any other purpose.
Following the expiration of such licenses in the Territory, the licenses granted in clause 2.1 with respect to Licensed Manufacturing Know-How will be fully paid-up and perpetual.
To the extent that any Licensed Manufacturing Know-How is in the Control of VistaGen but is in the possession of a VistaGen CMO (and is not in VistaGen’s possession), then during the Manufacturing Transfer Period, VistaGen will use Commercially Reasonable Efforts to facilitate the transfer of such Licensed Manufacturing Know-How from such VistaGen CMO to the Designated Manufacturer(s), and/or cause such VistaGen CMO to make such Licensed Manufacturing Know-How available to the Designated Manufacturer(s).
The [***] Agreement and ▇▇▇▇▇’▇ agreements with any other Permitted CMO/CRO that will have access to the AMGEN Cell Line or Sensitive Licensed Manufacturing Know-How shall provide for, among other things, (i) [***]; provided, (ii) [***], except as otherwise expressly contemplated in this Agreement and (iii) such additional provisions as are required to comply with the manufacturing and other limitations set forth in this Section 2.5.3 (such agreement, the “Permitted CMO/CRO Agreement”).
To the extent that any Licensed Manufacturing Know-How is in the Control of TheraVida but is in the possession of a Third Party CMO of TheraVida (and is not in TheraVida’s possession), Section 6.2(b) shall apply.
Roivant, in its sole discretion [***], may contract with any such TheraVida CMO for technical assistance (both on site and otherwise) in the transfer and demonstration of the Licensed Manufacturing Know-How that is necessary to manufacture Proprietary Drugs and Licensed Products.
Arena and its Affiliates have, and shall retain, all right, title and interest in and to the Arena Licensed IP, Arena Licensed Records, Arena Licensed Manufacturing Know-How, Arena Licensed Supply Records and any other intellectual property owned by Arena or its Affiliates as of the Effective Date, (other than the Purchased Intellectual Property) or developed by Arena or its Affiliates outside the scope of this Agreement during the Term.
For purpose of clarity, ▇▇▇▇▇ may at its discretion file new patent applications for Program Patents and may include in such applications data or discoveries included within the Licensed Know-How; provided, however, ▇▇▇▇▇, its Affiliates and Sublicensees may not file patent applications claiming any AMGEN Cell Line or any Licensed Manufacturing Know-How.

More Definitions of Licensed Manufacturing Know-How

Licensed Manufacturing Know-How has the meaning set forth in Section 2.5.

Licensed Manufacturing Know-How means (a) any data, information and know-how, other than Know-How, that is (i) not generally known, (ii) owned, licensed, or otherwise controlled by Sellers or its Affiliates as of the Closing Date, (iii) used and necessary, by or on behalf of Sellers or its Affiliates as of the Closing Date, for the manufacture of the Product and is useful or necessary for the manufacture of other products, and (iv) not related to any particular manufacturing facility.

Licensed Manufacturing Know-How means all Know-How that (a) is Controlled by VALNEVA or any of its Affiliates as of the Effective Date, (b) is Developed by VALNEVA during the Term of this Agreement, and (c) directly relates to the fill & finish Manufacture of the VALNEVA Product but does not include the Know-How relating to VALNEVA Drug Substance and/or related processes. The detailed scope of the Licensed Manufacturing Know-How is defined in the Technology Transfer Agreement.

Licensed Manufacturing Know-How means Sun’s proprietary design and manufacturing processes necessary or useful to manufacture the Products, including as described in Sun’s FDA 510(k) and Medicare PDAC regulatory filings, but in all cases as described in detail in Exhibit C, provided, however, that Licensed Manufacturing Know-How does not include any information to the extent that it: (i) was already legally in the possession and control of Tactile prior to its receipt from Sun; (ii) is independently derived by Tactile without use of the information described on Exhibit C; (iii) is or becomes a matter of public knowledge through no fault of Tactile; (iv) is disclosed by Sun to a third party without any duty of confidentiality to Sun; (v) is disclosed under operation of law; or (vi) is lawfully obtained from a third party under no obligation of confidentiality to Sun.

Licensed Manufacturing Know-How means Sun’s proprietary design and manufacturing processes necessary or useful to manufacture the Products, including as described in Sun’s FDA 510(k) and Medicare PDAC regulatory filings, but in all cases as described in detail in Exhibit C, provided, however, that Licensed Manufacturing Know- How does not include any information to the extent that it: (i) was already legally in the possession and control of Tactile prior to its receipt from Sun; (ii) is independently derived by Tactile without use of the information described on Exhibit C; (iii) is or becomes a matter of public knowledge through no fault of Tactile; (iv) is disclosed by Sun to a third party without any duty of confidentiality to Sun; (v) is disclosed under operation of law; or (vi) is lawfully obtained from a third party under no obligation of confidentiality to Sun.