LP Data Package definition

LP Data Package means all data, documentation, test results, and clinical and/or regulatory submissions, including Regulatory Materials, and correspondence (including all submissions, applications, and correspondence with/to the FDA, EMEA or other foreign governmental drug review and approval agency or entity), whether electronic or paper, relating to the pre-clinical and clinical research and development of Irofulven, the suitability of the drug for use in humans, and/or the manufacture or preparation of the Compound, which, as of the Effective Date and/or during the Term, is or becomes owned, controlled, in the possession of, or accessible to LP or its Affiliates and which is necessary or desirable for the conduct of the Program contemplated herein, including those referenced in Section 4.6 below.
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Examples of LP Data Package in a sentence

  • The mentioned license fee shall, irrespective of the before-mentioned, be refunded if LP breaches any material warranty or representation provided in this Agreement, or if LP fails to timely provide the LP Data Package to OV.

  • For clarity this includes the costs of access and digitization of the LP Data Package.

  • For purposes of clarity, all information and materials contained within the LP Data Package provided to OV shall be returned to, and exclusively owned by, LP upon termination of this Agreement as provided in subsection (a) above.

  • As between the Parties, OV shall be the legal and beneficial owner of all Regulatory Materials and Regulatory Approvals for the Product(s) in the Field in the Territory that are developed during the Term of this Agreement for the Program; provided that, LP remains at all times the legal and beneficial owner of LP Data Package.

  • LP owns certain intellectual property rights in and to the cancer drug Irofulven (CAS No. 158440-71-2), an alkylating DNA damage repair inhibitor, which rights include the LP Data Package (as defined herein).

  • LP licenses certain intellectual property rights in and to the cancer drug Irofulven, which rights include the LP Data Package under the Technology License Agreement from AF Chemicals, LLC, a Californian limited liability company having its principal office at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇.▇.▇.