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Contract analysis / technology-transfer-agreement.docx
technology-transfer-agreement.docx
1018-00006 · 10 clauses
High · 2 Medium · 5 Standard · 2
ARTICLE 1 — DEFINITIONS High
⚑ Non-compete / exclusivity restraint
ARTICLE 1 — DEFINITIONS 1.1 Definitions. Capitalized terms used but not otherwise defined in this Agreement shall have the meanings ascribed to them in the License Agreement. In addition to terms defined elsewhere in this Agreement, the following terms shall have the meanings set forth below: (a) "Acceptance Criteria" means the criteria set forth in Schedule 2 attached hereto that the Receiving Facility must satisfy
ARTICLE 2 — SCOPE OF TECHNOLOGY TRANSFER Medium
⚑ Liability cap to check against exposure
ARTICLE 2 — SCOPE OF TECHNOLOGY TRANSFER 2.1 Scope. Penterra shall transfer to Meridian (or Meridian's designated Receiving Facility) the complete Technology Transfer Package necessary to enable Meridian to independently manufacture, test, release, and package API and finished dosage form of Licensed Product (PPC-4187 (Penteracitinib), 25 mg and 50 mg film-coated tablets) in the Territory. The Technology Transfer sha
ARTICLE 3 — TRANSFER MILESTONES AND TIMELINE Medium
⚑ Assignment / subcontracting
ARTICLE 3 — TRANSFER MILESTONES AND TIMELINE 3.1 Transfer Milestones. The Technology Transfer shall be accomplished in accordance with the Transfer Milestones set forth in Schedule 3, which shall include, at a minimum, the following five (5) phases: (a) Phase 1 — Document Transfer (Months 1–6; Effective Date through April 20, 2024). During Phase 1, Penterra shall assemble, organize, and deliver the complete Technolog
ARTICLE 4 — ACCEPTANCE CRITERIA
ARTICLE 4 — ACCEPTANCE CRITERIA 4.1 General. Each Transfer Milestone shall be deemed complete only upon satisfaction of the corresponding Acceptance Criteria set forth in Schedule 2 attached hereto. The Acceptance Criteria are designed to provide objective, measurable standards for evaluating the successful completion of each phase of the Technology Transfer. The parties acknowledge that the ultimate objective of the
ARTICLE 5 — OBLIGATIONS OF PENTERRA (TRANSFEROR) Medium
⚑ Confidentiality undertaking
ARTICLE 5 — OBLIGATIONS OF PENTERRA (TRANSFEROR) 5.1 Delivery of Technology Transfer Package. Penterra shall assemble, organize, and deliver the complete Technology Transfer Package to Meridian and the Receiving Facility in accordance with the timeline set forth in Schedule 3 and the Technology Transfer Plan. Penterra shall use commercially reasonable efforts to ensure that all documents are accurate, current, comple
ARTICLE 6 — OBLIGATIONS OF MERIDIAN (TRANSFEREE) Standard
⚑ Commercial term
ARTICLE 6 — OBLIGATIONS OF MERIDIAN (TRANSFEREE) 6.1 Designation of Receiving Facility. Meridian shall designate the Receiving Facility within sixty (60) days of the Effective Date (i.e., by December 19, 2023) and shall notify Penterra in writing of the identity, location, regulatory status, and manufacturing capabilities of the Receiving Facility. The notification shall include: (a) the legal name and address of the
ARTICLE 7 — PERSONNEL AND TRAVEL Medium
⚑ Confidentiality undertaking
ARTICLE 7 — PERSONNEL AND TRAVEL 7.1 Penterra Personnel On-Site at Receiving Facility. Penterra shall provide on-site technical personnel at the Receiving Facility for a total of no fewer than the number of person-days specified in the Technology Transfer Plan during the Technology Transfer period, allocated across Phases 2 through 5. The Technology Transfer Plan shall specify the minimum and estimated number of pers
ARTICLE 8 — COSTS AND EXPENSES Standard
⚑ Commercial term
ARTICLE 8 — COSTS AND EXPENSES 8.1 Internal Costs. Except as otherwise expressly provided in this Agreement, each party shall bear its own internal costs (including personnel costs, overhead, and administrative expenses) associated with performing its obligations under this Agreement in connection with the Technology Transfer. 8.2 Out-of-Pocket Costs. Meridian shall reimburse Penterra for reasonable, documented, pre-
ARTICLE 9 — INTELLECTUAL PROPERTY High
⚑ Non-compete / exclusivity restraint
ARTICLE 9 — INTELLECTUAL PROPERTY 9.1 Ownership of Transferred Technology. All Know-How, Manufacturing Process information, Analytical Methods, CMC Documentation, and other proprietary technology and intellectual property transferred by Penterra to Meridian pursuant to this Agreement remain the exclusive property of Penterra. The transfer of the Technology Transfer Package does not convey to Meridian any ownership in
ARTICLE 10 — CONFIDENTIALITY Medium
⚑ Confidentiality undertaking
ARTICLE 10 — CONFIDENTIALITY 10.1 Confidential Information. All information disclosed by either party to the other party (or to the Receiving Facility or Transferring Facility, as applicable) in connection with the Technology Transfer, including without limitation the Technology Transfer Package, the Technology Transfer Plan, the Acceptance Criteria, progress reports, and all technical, scientific, business, financia