Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.
Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.
Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.
Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.
Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.
License Types (a) A Team License shall mean a subscription license that provides a limited number of licenses to a set amount of developers for a named Customer. Customer must procure enough active licenses for each individual who has Programmatic Access. A Team License only grants rights to a named Customer and does not extend any right, in any form, to any parent or subsidiary company of Customer. A Team License cannot be used as a floating license.
(b) A Project License shall mean a subscription license which covers one named Customer application. The license fees are based on the total number of developers working on a named project, regardless of whether such developers are directly using the Licensed Product. For the purposes of pricing and license administration, a “Project Group” is deemed to be a distinct Customer software team within a Customer’s business unit that works towards a distinct business purpose for the benefit of a single application. Customer is required to identify the name of each such Project Group to Syncfusion; such name must be unambiguous in nature. It is acknowledged and agreed by Customer that each identified Project Group shall exist for a valid business purpose and not just as a means for consolidating software licenses to minimize license fees that are otherwise due. If, in the sole opinion of Syncfusion, multiple Customer teams would each individually meet the above definition of a Project Group, such multiple teams shall not be combined for the purpose of consolidating licenses under a single Project Group. Customer is responsible for providing information about each such Project Group to Syncfusion. By entering into this Agreement, Customer represents that after the effective date, it will not withhold information that Syncfusion requires to properly license each such Project Group, and further agrees that any misrepresentation in this regard constitutes a material breach of this Agreement.
(c) A Division License shall mean a subscription license which will cover one named Division and allow for development work on more than one project within such Division. A Division shall mean a business unit within Customer’s organization that works towards a distinct business purpose. Customer is required to identify the name of such Division to Syncfusion; such name must be unambiguous in nature. License fee determinations will be at the sole discretion of Syncfusion and be based on such factors including, but not limited to, Customer’s Division size, developer count, and the scope of the Division’s business purpose. By entering into this Agreement, Customer acknowledges that it is responsible for providing information about the named Customer Division to Syncfusion sufficient for Syncfusion to price the Division License, and Customer represents that it will not withhold information that Syncfusion requires to properly license each such named Customer division, and further agrees that any misrepresentation in this regard constitutes a material breach of this Agreement.
(d) A Global License shall mean a subscription license for all development for a named Customer, where the license fees are based on the overall size of a named Customer. A Global License only grants rights to a named Customer and does not extend any right, in any form, to any parent or subsidiary company of Customer.
(e) A Retail License shall mean a single named user, non-transferable license to use the Licensed Product. Retail Licenses will only made available to Customers in Syncfusion’s sole discretion and only when the number of such End-Users is finite and readily ascertainable. Accordingly, Syncfusion will make a determination as to whether or not the provision of Retail Licenses is appropriate under the circumstances applicable to any given Customer, and Syncfusion reserves the right, in its sole discretion, to refuse to make available Retail Licenses to a Customer and instead require a given Customer to procure a Project License, Division License, or Global License as circumstances dictate. A Retail License only grants rights to a named Customer and does not extend any right, in any form, to any parent or subsidiary company of Customer.
SOURCE CODE ESCROW FOR LICENSED PRODUCT If Source Code or Source Code escrow is offered by either Contractor or Product manufacturer or developer to any other commercial customers, Contractor shall either: (i) provide Licensee with the Source Code for the Product; or (ii) place the Source Code in a third party escrow arrangement with a designated escrow agent who shall be named and identified to the State, and who shall be directed to release the deposited Source Code in accordance with a standard escrow agreement acceptable to the State; or (iii) will certify to the State that the Product manufacturer/developer has named the State, acting by and through the Authorized User, and the Licensee, as a named beneficiary of an established escrow arrangement with its designated escrow agent who shall be named and identified to the State and Licensee, and who shall be directed to release the deposited Source Code in accordance with the terms of escrow. Source Code, as well as any corrections or enhancements to such source code, shall be updated for each new release of the Product in the same manner as provided above and such updating of escrow shall be certified to the State in writing. Contractor shall identify the escrow agent upon commencement of the Contract term and shall certify annually that the escrow remains in effect in compliance with the terms of this clause. The State may release the Source Code to Licensees under this Contract who have licensed Product or obtained services, who may use such copy of the Source Code to maintain the Product.
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.
Procurement of Goods and Services (a) If the HSP is subject to the procurement provisions of the BPSAA, the HSP will abide by all directives and guidelines issued by the Management Board of Cabinet that are applicable to the HSP pursuant to the BPSAA.
(b) If the HSP is not subject to the procurement provisions of the BPSAA, the HSP will have a procurement policy in place that requires the acquisition of supplies, equipment or services valued at over $25,000 through a competitive process that ensures the best value for funds expended. If the HSP acquires supplies, equipment or services with the Funding it will do so through a process that is consistent with this policy.
