Development Information. During the construction process, Developer will provide to Borrower, Company and BR Member copies of all Loan-related and draw-related information, including but not limited to monthly copies of the construction draws, construction draws top sheets with budget-versus-actual information to Borrower, Company and BR Member, plus full physical access to the Property and all documentation in connection with the development and construction of the Project.
Development Information. 13 5.3.1. Information for Regulatory Submissions.. 13 5.3.2. Reports to Development Committee........ 13 5.3.3. Regulatory Submissions.................. 13 5.3.4. Adverse Event Information............... 13 5.4.
Development Information. 16 5.2.1. Reports and Information Exchange ................. 16 5.2.2. Adverse Reaction Reporting ....................... 17 5.2.3. Clinical and Regulatory Audits ................... 17 5.3. Regulatory Approval Filings .............................. 17 5.4. Facilities Visits ........................................ 18
Development Information. ARCHEMIX will provide EYETECH and the JRC on a quarterly basis during the Research Term, with notice of all material information applicable to the Field known to ARCHEMIX about any Program Compound (the “Development Information”), including analysis results and raw data which the JRC should reasonably require to assess whether a given Program Compound meets the Early Selection Criteria or which EYETECH should reasonably require in order for EYETECH (i) to exercise its rights under this Agreement, and (ii) to decide, in EYETECH’s sole discretion, whether to exercise the License Option with respect to such Program Compound or Compound Candidate, as applicable. The Development Information shall also include any previously undisclosed information with respect to ARCHEMIX Technology, which is important for a scientific and commercial evaluation of the Program Compound. EYETECH expects to utilize evaluation criteria such as those set forth on Appendix 1, without limitation, in its assessment of whether to license Program Compounds or Compound Candidates.
Development Information. COMPANY shall, subject to any rights any Sublicensees or other third parties may have with respect to Development Information, grant to LICENSOR a right for LICENSOR to access and to refer to all Development Information delivered or required to be delivered pursuant to Section 12.7, and to provide a copy thereof to potential licensees of the Licensed Patents (under conditions of confidentiality consistent with Article 11), solely for use in LICENSOR’s efforts to license the Licensed Patents to any third party; LICENSOR shall not be entitled to license, grant, or transfer to any third party any rights in such Development Information. In the event LICENSOR agrees in writing to material economic terms with a third party concerning the grant of a license to such third party under the Licensed Patents formerly licensed to COMPANY hereunder, LICENSOR shall provide written notice thereof to COMPANY and COMPANY shall enter into good faith negotiations with such third party concerning the granting of rights to, or transfer of title in, the Development Information to such third party on commercially reasonable terms, subject to any rights any Sublicensees or other third parties may have with respect to any of the foregoing that survive termination of this Agreement.
Development Information. If the Alternate UBC Plan is in effect and/or as to all clinical development of a UBC Development Compound outside the United States, (i) DuPont Merck shall keep Mitotix informed as to the progress of DuPont Merck in the development and testing of all UBC Development Compounds and UBC Products and the preparing, filing and obtaining of the approvals necessary for marketing, (ii) within thirty (30) days following the end of the first month of each Calendar Quarter following the designation of a UBC Development Compound, DuPont Merck shall provide to Mitotix a reasonably detailed report which shall describe the progress of the development and testing of the UBC Products incorporating such UBC Development Compounds. DuPont Merck may satisfy its reporting obligation hereunder by providing an oral report to the Collaborative Policy Setting Committee within such thirty (30) day period, provided that a written report of the oral presentation is delivered to Mitotix no later than thirty (30) days after the oral report is made to the Collaborative Policy Setting Committee. In addition, DuPont Merck shall provide Mitotix with a minimum of three (3) months’ advance notice of the contemplated filing of an IND or an NDA, and DuPont Merck shall provide Mitotix with a report on all material regulatory submissions at least forty-five (45) days prior to the date of such submissions, or any major amendments or supplements thereto within ten (10) business days of filing thereof. DuPont Merck shall provide to Mitotix in a timely manner copies of any material regulatory submission, or amendments thereof, reasonably requested by Mitotix or, alternatively shall provide Mitotix reasonable access to each such material regulatory submission or amendments thereof at DuPont Merck’s offices, for review and copying by Mitotix.
Development Information. Within ninety (90) days after the Effective Date, resTORbio will provide Novartis with a high level summary development plan setting forth the anticipated Development activities to be conducted by resTORbio and its Affiliates and sublicensees related to the Compounds and Products during the following 18 month period (the “Development Plan”). No later than ninety (90) days after each anniversary of the Effective Date, until the approval of the first NDA or MAA for a Product, resTORbio will provide Novartis an updated Development Plan providing, in reasonable detail, the [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED Development activities conducted by resTORbio and its Affiliates and sublicensees related to Compounds and Products during the immediately preceding year and its anticipated plans for Development of the Compounds and Products for next 18 month period. In addition to this annual report, resTORbio will provide to Novartis a high level summary of all Development activities that resTORbio, its agents, or their sublicensees have conducted in the prior six month period until the approval of the first NDA or MAA for a Product. resTORbio may revise the Development Plan or any update thereto in its sole discretion, subject to satisfaction of its obligations under Section 5.2.
Development Information. 28 4.11. CESSATION OF TRANSCEND BUSINESS ................... 28 ARTICLE 5. MANAGEMENT ........................................ 28 5.1 JOINT DEVELOPMENT TEAM ............................ 28 5.1.1. GENERAL .................................. 28 5.1.2. RESPONSIBILITIES ......................... 28 5.1.3. MEETINGS ................................. 30 5.1.4. REPRESENTATIVES .......................... 30 5.1.5. ACTIONS .................................. 30 5.2. JOINT MARKETING TEAM .............................. 30 5.2.1. GENERAL .................................. 30 5.2.2. MEETINGS ................................. 30 5.2.3. REPRESENTATIVES .......................... 30 5.2.4. ACTIONS .................................. 31 5.3. JOINT STEERING COMMITTEE .......................... 31 5.3.1. GENERAL .................................. 31 5.3.2. CHAIR .................................... 31 5.3.3. MEETINGS ................................. 31 5.3.4. DISAGREEMENTS ............................ 32
Development Information. Each Party will (a) provide the other Party with a copy of all submissions to be made by such Party to regulatory authorities prior to the date of such submissions in sufficient time to enable the other Party to comment on such submission, and (b) promptly provide the other Party with the results of all toxicology and pharmacology studies and clinical trials conducted by, or under the supervision of, such Party, with respect to the Licensed Products.
Development Information. During the construction process, the TCR Member will provide or cause the Developer to provide to the Company and BR Member copies of all draw-related information for the Loan, including but not limited to monthly copies of the construction draws and construction draws top sheets with budget-versus-actual information, plus full physical access to the Property and all documentation of the Company in connection with the development and construction of the Project.
