Collegium Documentation definition

Collegium Documentation means all documentation, reports, case report forms, data, information and the like, including all notes, summaries and analyses related thereto, in whatever form or media, in the possession or Control of Collegium or any Affiliate thereof, which result from or otherwise describe (i) pre-clinical, clinical, or other research and development activities related to any Licensed Product conducted by or for Collegium, its Affiliates, or any Sublicensees in the Territory, including but not limited to Phase IV Studies or manufacturing- or formulation-related activities, and/or any results thereof, (ii) information obtained by or on behalf of Collegium or Affiliate thereof concerning the use or administration of Licensed Products, including but not limited to AEs, ADRs, ADEs, and/or SAEs, or (iii) or other Collegium Know-How contained or referenced in any Governmental Approvals or Regulatory Filings.
Collegium Documentation means all documentation, reports, case report forms, data, information and the like, including all notes, summaries and analyses related thereto, in whatever form or media, in the possession or Control of Collegium or any Affiliate thereof, which result from or otherwise describe (i) pre-clinical, clinical, or other research and development activities related to any Licensed Product conducted by or for Collegium, its Affiliates, or any Sublicensees in the Territory, including but not limited to Phase IV Studies or manufacturing- or formulation-related activities, and/or any results thereof,(ii) information obtained by or on behalf of Collegium or Affiliate thereof concerning the use or administration of Licensed Products, including but not limited to AEs, ADRs, ADEs, and/or SAEs, or (iii) or other Collegium Know-How contained or referenced in any Governmental Approvals or Regulatory Filings.

Examples of Collegium Documentation in a sentence

  • Collegium shall, upon reasonable request of BDSI, promptly provide BDSI with copies of any Collegium Documentation, Collegium Know-How, Collegium Patents, or Patents Covering any Collegium Product-Specific Improvements or Controlled Collegium BEMA Improvements (and any Know-How with respect thereto and/or Patents Covering such Collegium BEMA Improvements) to the extent not previously provided to BDSI and BDSI has been granted rights thereto pursuant to this Agreement.

Related to Collegium Documentation

  • Program Documentation refers to the user manuals, help windows, readme files for the Services and any Oracle Software. You may access the documentation online at xxxx://xxxxxx.xxx/contracts or such other address specified by Oracle.

  • Related Documentation means, with respect to Software, all materials, documentation (including control documentation utilized in connection with an audit), specifications, technical manuals, user manuals, flow diagrams, file descriptions and other written information that describes the function and use of such Software, but excluding source code.

  • Design Documentation means all:

  • Product Documentation means the specific materials listed under “Documentation” at xxx.xxxxxx.xxx/xxxxx, as updated by Vocera from time to time.

  • Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical Data).

  • User Documentation means that documentation regarding the operation, guidelines and features and functionality of Clover Insights that is made available to you from time to time at the website, by internet link or otherwise. User Documentation may be modified from time to time by First Data or its third party provider(s).

  • Limited Documentation Program The guidelines under which the Seller generally originates Mortgage Loans principally on the basis of the Loan-to-Value Ratio of the related Mortgage Loan and the creditworthiness of the Mortgagor.

  • Technical Documentation means designs, reports, photographs, drawings, plans, specifications, computer software, surveys, calculations and other data, information and material collected, computed, drawn or produced, including computer print-outs.

  • Software Documentation means software information, being technical information used, or useful in, or relating to the design, development, use or maintenance of any version of a software programme.

  • Service documentation means all records and information on one or more documents, including documents that may be created or maintained in electronic software programs, created and maintained contemporaneously with the delivery of services, and kept in a manner as to fully disclose the nature and extent of services delivered that shall include the items delineated in paragraph (E) of this rule to validate payment for medicaid services.

  • Flood Documentation means, with respect to each Mortgaged Property located in the United States of America or any territory thereof, (i) a completed “life-of-loan” Federal Emergency Management Agency standard flood hazard determination (to the extent a Mortgaged Property is located in a Special Flood Hazard Area, together with a notice about Special Flood Hazard Area status and flood disaster assistance duly executed by the Borrower and the applicable Loan Party relating thereto) and (ii) a copy of, or a certificate as to coverage under, and a declaration page relating to, the insurance policies required by Section 5.02(c) hereof and the applicable provisions of the Security Documents, each of which shall (A) be endorsed or otherwise amended to include a “standard” or “New York” lender’s loss payable or mortgagee endorsement (as applicable), (B) name the Collateral Agent, on behalf of the Secured Parties, as additional insured and loss payee/mortgagee, (C) identify the address of each property located in a Special Flood Hazard Area, the applicable flood zone designation and the flood insurance coverage and deductible relating thereto and (D) be otherwise in form and substance reasonably satisfactory to the Collateral Agent.

  • Account Documentation means any and all Account information, credit applications, Cardholder Agreements and change in terms notices, Charge Transaction Data, charge slips, credit slips, payments, credit information and documents or forms of any type and in any media relating to the Program, excluding materials used for advertising or solicitations.

  • Security Documentation means all documents and information made available by Google under Section 7.5.1 (Reviews of Security Documentation).

  • Acquisition Documentation collectively, the Acquisition Agreement and all schedules, exhibits and annexes thereto and all side letters and agreements affecting the terms thereof or entered into in connection therewith.

  • Supporting Documentation means the documents listed in Schedule A of this Certificate which forms part of this

  • Participant Documentation means the agreements (together with any applicable schedules, exhibits or appendices thereto required by BSEF) in form and substance acceptable to BSEF, that are required to be executed and delivered to BSEF before a Person may access the SEF operated by BSEF as a Participant. Participant Documentation shall not include DMA Customer Documentation.

  • Computer software documentation means owner's manuals, user's manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer software or provide instructions for using the software.

  • Design Development Documents means the Drawings, Specifications and other documents prepared by the Trade Contractor that establish and describe the size and character of the Trade Contractor Work as to architectural, civil, structural, mechanical and electrical systems, graphics and signage, and other elements, and which include typical construction details, equipment layouts and specifications that identify major materials and systems.

  • ISM Code Documentation includes, in respect of a Ship:

  • Implementation Agreement means the Implementation Agreement dated ……… by and between the GOB, PGCB and the Company in connection with the Project, and also includes any amendment of it made from time to time;

  • Co-Documentation Agents as defined in the preamble hereto.

  • Development Agreement has the meaning set forth in the Recitals.

  • Co-Documentation Agent as defined in the preamble hereto.

  • RFP Documents means the following documents to be entered into by the parties to the respective agreements in connection with the supply of power:

  • Streamlined Documentation Mortgage Loan Any Mortgage Loan originated pursuant to the Seller's Streamlined Loan Documentation Program then in effect.

  • Project Management Agreement means the agreement dated the 20th February 1985 made between the Trustee and the Manager providing for the Manager to manage and co‑ordinate the development and construction of the Resort and includes, if that agreement is terminated, any other agreement in like and similar terms made with the prior consent of the Minister;