Established Commercial Infrastructure Sample Clauses

Established Commercial Infrastructure. For the purpose of this Agreement, “Established Commercial Infrastructure” means, with respect to Cytokinetics, it has plans to launch within [*] or has launched one or more product(s), either under this Agreement or otherwise, that address a comparable market opportunity in the applicable therapeutic area. For clarity, Cytokinetics shall be deemed to have an Established Commercial Infrastructure in a country if Cytokinetics has received Marketing Approval for Tirasemtiv in such country, is readying for the launch of or launched Tirasemtiv, or is promoting one (1) or more other product(s), either under this Agreement or otherwise, or has in place the requisite capabilities to market, sell, and distribute Tirasemtiv in any Retained Indication or a Collaboration Product for [*] Indication. In the event that [*] in accordance with [*] set forth in Section [*].
Sample 1
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Established Commercial Infrastructure. For the purpose of this Agreement, “Established Commercial Infrastructure” means, with respect to Cytokinetics, it has plans to launch within [ * ] or has launched one or more product(s), either under this Agreement or otherwise, that address a comparable market opportunity in the applicable therapeutic area. For clarity, Cytokinetics shall be deemed to have an Established Commercial Infrastructure in a country if Cytokinetics has received Marketing Approval for Tirasemtiv or a Fast Skeletal Regulatory Activator in such country, is readying for the launch of or launched Tirasemtiv or a Fast Skeletal Regulatory Activator, or is promoting one (1) or more other product(s), either under this Agreement or otherwise, or has in place the requisite capabilities to market, sell, and distribute Tirasemtiv or a Fast Skeletal Regulatory Activator in any Indication or a Collaboration Product for [ * ] Indication. In the event that [ * ], in accordance with [ * ] set forth in Section [ * ].
Sample 1

Related to Established Commercial Infrastructure

  • Infrastructure (a) The Borrower has and will maintain a sufficient infrastructure to conduct its business as presently conducted and as contemplated to be conducted following its execution of this Agreement.

  • Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall:

  • Projects 3.3.1 Exult Supplier shall perform the impact analysis as described in Section 4.

  • Security System Landlord shall not be obligated to provide or maintain any security patrol or security system. Landlord shall not be responsible for the quality of any such patrol or system which may be provided hereunder or for damage or injury to Tenant, its employees, invitees or others due to the failure, action or inaction of such patrol or system.

  • Data Processing System, Program and Information (a) The Investment Company shall not, solely by virtue of this Agreement, obtain any rights, title and interest in and to the computer systems and programs, including all related documentation, employed by FTIS in connection with rendering services hereunder; provided however, that the records prepared, maintained and preserved by FTIS pursuant to this Agreement shall be the property of the Investment Company.

  • Review Systems The Asset Representations Reviewer will maintain and utilize an electronic case management system to manage the Tests and provide systematic control over each step in the Review process and ensure consistency and repeatability among the Tests.

  • Site Access The Buyer agrees to RELEASE, INDEMNIFY AND HOLD HARMLESS the Seller Indemnitees from and against the entirety of any Adverse Consequences that are suffered by the Seller Indemnitees arising out of, resulting from or relating to any field visit or other due diligence activities relating to any performance of the Diligence Activities to the extent caused by acts or omissions of any Buyer Party or Buyer Diligence Representative, even if such Adverse Consequences arise out of or result from, solely or in part, the sole, active, passive, concurrent or comparative negligence, strict liability or other fault or violation of Law of or by the Seller Indemnitees, except Adverse Consequences to the extent resulting from the gross negligence or willful misconduct of the Seller Indemnitees.

  • Master Feeder Structure If permitted by the 1940 Act, the Board of Trustees, by vote of a majority of the Trustees, and without a Shareholder vote, may cause the Trust or any one or more Series to convert to a master feeder structure (a structure in which a feeder fund invests all of its assets in a master fund, rather than making investments in securities directly) and thereby cause existing Series of the Trust to either become feeders in a master fund, or to become master funds in which other funds are feeders.

  • 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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