Common use of RPI Manufacture Clause in Contracts

RPI Manufacture. Subject to the limitations hereunder, RPI has the exclusive right to manufacture and/or have manufactured the Ribozyme component of the Ribozyme Products ("bulk drug") and to manufacture Ribozymes for research ("Research Ribozymes") pursuant to the R&D Plan. RPI shall manufacture all of the worldwide requirements for the bulk drug for the Ribozyme Products and sell such bulk drug as stable bulk material to LILLY for final filling/finishing and packaging. The bulk drug responsibilities will be described in a separate Manufacturing Requirements Document ("MRD") for clinical and commercial materials. The MRD will be included in a separate Ribozyme Manufacture and Supply Agreement which shall be formalized at the recommendation of the JDT and shall contain all terms and conditions of this Agreement and those that are standard for a pharmaceutical manufacturing agreement (such terms and conditions as outlined in Appendix E), including the obligation of RPI to comply with all rules and regulations of the FDA or any other applicable regulatory agency. The Term of the Ribozyme Manufacture and Supply Agreement shall be consistent with the Royalty Term under this Agreement. The Ribozyme Manufacture and Supply Agreement shall incorporate this Agreement by reference in its entirety and vice versa.

Appears in 3 contracts

Samples: Collaboration and License Agreement (Ribozyme Pharmaceuticals Inc), License Agreement (Ribozyme Pharmaceuticals Inc), License Agreement (Ribozyme Pharmaceuticals Inc)

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RPI Manufacture. Subject to the limitations hereunder, RPI has the exclusive right to manufacture and/or have manufactured the Ribozyme component of the Ribozyme Products ("bulk drug") and to manufacture Ribozymes for research ("Research Ribozymes") pursuant to the R&D Plan. RPI shall manufacture all of the worldwide requirements for the bulk drug for the Ribozyme Products and sell such bulk drug as stable bulk material to LILLY for final filling/finishing and packaging. The bulk drug responsibilities will be described in a separate Manufacturing Requirements Document ("MRD") for clinical and commercial materials. The MRD will be included in a separate Ribozyme Manufacture and Supply Agreement which shall be formalized at the recommendation of the JDT and shall contain all terms and conditions of this Agreement and those that are standard for a pharmaceutical manufacturing agreement (such terms and conditions as outlined in Appendix APPENDIX E), including the obligation of RPI to comply with all rules and regulations of the FDA or any other applicable regulatory agency. The Term of the Ribozyme Manufacture and Supply Agreement shall be consistent with the Royalty Term under this Agreement. The Ribozyme Manufacture and Supply Agreement shall incorporate this Agreement by reference in its entirety and vice versa.

Appears in 1 contract

Samples: Research Collaboration and License Agreement (Ribozyme Pharmaceuticals Inc)

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