Product Data Package shall include the following information and data related to the Product in the possession or control of Gilead as of the Effective Date: (a) the Regulatory Documents; (b) pre-clinical and clinical development protocols, data, and reports; (c) manufacturing development technical reports; (d) toxicology reports; and (e) such other information and data specifically identified in Exhibit B attached hereto.
Product Data Package means the following information and data directly related to PDX in the possession or control of Licensor as of the Effective Date: (a) all regulatory documents filed and maintained in connection with PDX; (b) pre-clinical and clinical development protocols, data, and reports; (c) manufacturing development technical reports; (d) toxicology reports; and (e) such other information and data specifically identified in Exhibit C attached hereto.
Product Data Package means any and all files, data, records and other Information (including without limitation regulatory documents, pre-clinical and clinical protocols, data, and reports, product complaint files, and adverse event files) relating to development of PPAR-d Compounds or PPAR-d Products anywhere in the world, to the extent such files, data, records or Information are Controlled by Janssen or its Affiliates.
Examples of Product Data Package in a sentence
Gilead shall be under no obligation to convert to electronic format any portion of the Product Data Package that currently is available only in printed format.
The clinical data portion of the Product Data Package shall be provided to EyeTech in computer-readable format, where available, and otherwise in printed format.
Allos shall co-operate with Licensor in identifying specific data and information that it considers to be part of the Product Data Package for PDX that is not listed in Exhibit C.
Exhibit C shall --------- include a notation indicating the format in which all other portions of the Product Data Package shall be provided.
The [ * ] portion of the Product Data Package shall be provided to Tularik [ * ].
More Definitions of Product Data Package
Product Data Package shall include the following information and data directly related to the Product in the tangible possession or control of Lilly as of the Effective Date: (a) Regulatory Documents; (b) pre-clinical and clinical development protocols, data, and reports; (c) manufacturing development technical reports; (d) toxicology reports; and (e) such other information and data specifically identified in EXHIBIT C attached hereto. EXHIBIT C shall represent a complete listing of the information and data included in Product Data Package, as such term is used in this Agreement.
Product Data Package means any and all files, data, records and other Information (including without limitation regulatory documents, pre-clinical and clinical protocols, data, and reports, product complaint files, and adverse event files) relating to development of PPAR-d Compounds or PPAR-d Products anywhere in the world, to the extent such files, data, records or Information are Controlled by Xxxxxxx or its Affiliates.
Product Data Package means the information and data listed on Exhibit C.
Product Data Package means the following information and data directly related to the Licensed Product in the tangible possession or control of BWH as of the Effective Date: (a) the regulatory documents for the Phase I/II investigating E2F Decoy for patients undergoing infrainguinal arterial bypass grafts (PREVENT trial), and (b) clinical protocols, data, and reports regarding such trial.
Product Data Package means the information and data listed on Exhibit C. 1.52 “Product Liability Claims” has the meaning set forth in Section 6.1(c). 1.53 “Project Technology” means confidential information and/or proprietary technical information, data, know-how, assays, procedures, Biological Materials, or other information within the Field conceived, developed, or acquired by Shionogi or Lilly during the term of the Collaborative Project and as a result of work on the Collaborative Project. 1.54 “Regulatory Approval” means (a) in the United States, approval by the FDA of an Application for Marketing Authorization and satisfaction of any related applicable FDA registration and notification requirements (if any), and (b) in any country or territory other than the United States, approval by Regulatory Authorities having jurisdiction over such country or territory of a single Application or set of Applications for Marketing Authorization and any other approvals required to market and sell pharmaceutical products in such country or territory. 1.55 “Regulatory Authority” means the FDA in the United States, and the equivalent regulatory authority or governmental entity having the responsibility, jurisdiction, and authority to approve the manufacture, use, importation, packaging, labeling, marketing, and sale of pharmaceutical products in any country or jurisdiction other than the United States. 1.56 “Regulatory Documents” means (a) with respect to the Compound referred to as S-5920/LY315920, United States Investigational New Drug No. 49,958 filed on February 12, 1996; (b) with respect to the Compound referred to as S-3013/LY333013, United States Investigational New Drug No. 55,091 filed on January 27, 0000, Xxxxxx Xxxxxx Investigational New Drug No. 59,457 filed on December 13, 1999, and United States Investigational New Drug No. 59,458 filed on December 13, 1999; and (c) all amendments, supplements, and reports related to the documents contained in (a) and (b). 1.57 “Shionogi Technology” means Biological Materials, Compounds, technical information, data, and know-how in the Field developed or acquired by Shionogi [***], and which Shionogi licensed to Lilly under the Collaboration Agreement. 1.58 “Technology Transfer Letter Agreement” has the meaning set forth in the fifth paragraph of the Recitals to this Agreement. 1.59 “Territory” means the entire world except for Japan. 1.60 “Third Party” means any entity other than Lilly, Shionogi, or Anthera, or an Affiliate of any of them. ...
Product Data Package shall include the following information and data directly related to the Product in the tangible possession or Control of Lilly as of the Effective Date: .1 the Regulatory Documents; .2 the pre-clinical and clinical development protocols, data, and reports;
Product Data Package shall include the following information and data related to the Product in the possession or control of Immunotech as of the Effective Date: (a) the Regulatory Documents; (b) pre-clinical and clinical development protocols, data, and reports; (c) manufacturing development technical reports; (d) toxicology reports; and (e) such other information and data specifically identified in Exhibit B attached hereto. Items a, b, c are currently in process and Immunotech upon completion of these will provide Xxxxx the necessary information, where applicable.