Common use of Development Information Clause in Contracts

Development Information. DuPont Merck shall keep Mitotix informed as to the progress of DuPont Merck in the development and testing of all CDK Development Compounds and CDK Products and the preparing, filing and obtaining of the approvals necessary for marketing. Within thirty (30) days following the end of each Calendar Quarter following the designation of a CDK Development Compound, DuPont Merck shall provide to Mitotix a reasonably detailed report which shall describe the progress of the development and testing of the CDK Products incorporating such CDK 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. 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.

Appears in 1 contract

Sources: Collaborative Research, Development and Marketing Agreement (GPC Biotech Ag)

Development Information. DuPont Merck Each Party agrees to keep the other informed of its activities under this Amended and Restated Agreement. WYETH shall keep Mitotix Ligand informed as to the progress of DuPont Merck in the development Exploratory Development and testing Full Development of all CDK Development Research Compounds and CDK Products under this Amended and Restated Agreement and the preparing, filing and obtaining of the approvals necessary for marketing. Within thirty (30) days following after the end of each Calendar Quarter six (6) month period following the designation commencement of a CDK Exploratory Development by WYETH of the first Research Compound, DuPont Merck WYETH shall provide to Mitotix Ligand a reasonably detailed written report which shall describe the progress of the development Exploratory Development and/or Full Development of Research Compounds and testing Products under this Amended and Restated Agreement in the form of the CDK Products incorporating such CDK Development Compoundstemplate attached hereto as Attachment 5.3 for each Research Compound and Product. DuPont Merck may satisfy its reporting obligation hereunder by providing an oral report to Such update would additionally include 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 latest copy of an IND or an NDA. DuPont Merck shall provide Mitotix with a report on all material regulatory submissions at least forty-five Investigational Drug Brochure (45IDB) days prior to the date of such submissions, or and any major amendments or supplements thereto within ten (10) business days of filing updated versions thereof. DuPont Merck shall provide to Mitotix Such update would additionally include a list of all Wyeth solely owned Patent Rights, other than Patent Rights with claims which read upon a Wyeth Compound Product or a Wyeth Compound or the process of manufacture or use of a Wyeth Compound Product or Wyeth Compound. Additionally, Ligand would be informed, in a timely manner copies fashion, of any material regulatory submissionserious adverse events that might occur with a Research Compound or Product and, subject to the provisions of Article 14 hereof, of any publications or presentations (including investor presentations) made that refer to a Research Compound or Product. Notwithstanding the foregoing, Wyeth's obligations under this Section 5.3 to provide the latest copy of an Investigational Drug Brochure (IDB) and any updated versions thereof and the list of all Wyeth solely owned Patent Rights as described above shall no longer apply in the event of Ligand's transfer or sale of all or substantially all of its business, or amendments thereofin the event of Ligand's merger or consolidation or change in control or similar transaction. For the avoidance of doubt, reasonably requested by Mitotix orin all events, alternatively Wyeth's obligations to provide information and reports under this Section 5.3, other than Wyeth's obligation to provide the latest copy of an Investigational Drug Brochure (IDB) and any updated versions thereof and the list of all Wyeth solely owned Patent Rights as described above, shall provide Mitotix reasonable access to each such material regulatory submission or amendments thereof at DuPont Merck’s offices, for review and copying by Mitotixcontinue.

Appears in 1 contract

Sources: Research, Development and License Agreement (Ligand Pharmaceuticals Inc)

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 CDK UBC Development Compounds and CDK UBC Products and the preparing, filing and obtaining of the approvals necessary for marketing. Within , (ii) within thirty (30) days following the end of the first month of each Calendar Quarter following the designation of a CDK 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 CDK UBC Products incorporating such CDK 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.

Appears in 1 contract

Sources: Collaborative Research, Development and Marketing Agreement (GPC Biotech Ag)