Contract Negotiation
There are several offices that negotiate agreements: OCR Legal negotiates non-Abramson Cancer Center (ACC) clinical research agreements with industry partners; ACC Legal Affairs negotiates cancer-related clinical research agreements with industry partners; the Office of Research Services (ORS) manages research agreements with federal and not- for-profit partners and funders, and the Penn Center for Innovation (PCI) negotiates agreements with industry partners for research that does not involve human participants (basic and translational research primarily) or IRB review. When research projects receive funding from multiple sources (federal, not-for-profit and for-profit sources), and/or involves both basic science and clinical research activities, the contracting offices confer to decide which is the most appropriate office to negotiate the agreement(s) and this decision is communicated to the investigator.
TYPES OF AGREEMENTS THAT FACILITATE FUNDING/ RESEARCH
| Agreement | Description |
|---|---|
| Clinical Trial Agreement (CTA) | A clinical trial agreement is the instrument that enables Penn's participation as a site in a clinical trial. The clinical trial could either be industry-initiated or investigator-initiated. |
| Sponsor Research Agreement (SRA) | Agreements used when a company provides funding to Penn for a particular researcher or researchers to pursue a specific area of research during a defined timeframe. |
| Collaborative Research Agreement (CRA) | A binding agreement between organizations that are cooperating in the conduct of a research program which defines the obligation each party has to the others participating in the collaborative research effort. |
| Confidential Disclosure Agreement (CDA) | Agreements that govern the exchange of confidential information between two or more parties for certain evaluation purposes. |
| Service Agreement | A written contract to engage an outside party to perform routine testing, standardized procedures, or services where the outcomes are not likely to result in the addition of new knowledge or publishable information |
| Material Transfer Agreement (MTA) | Agreements that govern the transfer of research material between organizations. |
| Data Usage Agreement (DUA) | Generally, these are agreements that govern the transfer and use of data between organizations, where the data is nonpublic or otherwise subjects to some restrictions of its use. |
| Manufacturing / Development Agreements | Agreements that cover the manufacture of a product, or development activities relating to product manufacture |
| Sponsor Research Agreement (SRA) | Agreements used to outline quality activities to various parties. |
| Collaborative Research Agreement (CRA) | Agreements used to change or correct the terms of an existing agreement |
| Confidential Disclosure Agreement (CDA) | Agreements between Penn and sub-site in situations where a prime/funding agreement designates that Penn will manage sub-sites in the performance of a clinical trial |
| Service Agreement |
|
Frequently Asked Questions
A: Anytime you are partnering with a person or entity outside of Penn, an agreement contract is needed to establish a legally binding, written understanding., which The agreement establishes parameters and expectations, which help to control the risk of misunderstandings and ambiguity. Agreements facilitate many things including, funding of research, transfer of materials, bio samples, and/ or data, collaboration between two or more parties, commercial development of a Penn product, device, or intervention, etc. Once contract negotiations are finalized it an agreement must be signed by a Penn authorized signatory to be legally valid and binding. Each contracting office has authorized signatories on staff.
- Corporate funded projects- Requests should be submitted in PennEra and upload any supporting documents to the PennEra record. Simultaneously, send a notice to the OCR Legal mailbox and request parallel review {termed “parallel review” because the agreement and budget are meant to be negotiated in parallel}. You will receive a notice from the negotiator assigned to the agreement. *For expediency, you are advised to simultaneously finalize your budget, submit the study materials to the IRB, and, if applicable, any conflict of interest, for their respective reviews.
- Corporate partnered, non-monetary, agreements- Requests, accompanied by all supporting documents should be uploaded into the Research Inventory System.
A: A full list of master agreements can be found in this document. Master agreements help streamline the negotiation process with industry partners by delineating, in one agreement, the terms that will govern future research projects set forth in specific statements of work, or work orders, falling under the Master agreement.
A: Vendormate is a 3rd party vendor Penn Medicine uses to back ground check pharmaceutical company representatives, and their immunization status. This to mostly protect patients especially immunocompromised patients in clinic spaces. Registration in Vendormate costs $250 per year to register. This requires yearly renewal by the company, and updates of the representatives immunization records. The cost for this is included in the budget template by OCR Finance (search for Prospective Reimbursement Analysis in Budget category) so teams can incorporate it before they negotiate with the pharmaceutical sponsor. The pharmaceutical representative category is also extended to CRO/ sponsor monitors that will be in clinic spaces.
- The link below is a brief step by step of how a Pharmaceutical vendor rep registers on the platform, and the screen shot below is that of the main website, and video tutorial that the vendor can accesses at: https://registersupplier.ghx.com/reg/network/vendor/
- Step-by-Step Link: https://www.med.upenn.edu/ocrobjects/attach/2020-06_Vendormate.pdf
- The policy that refers to Vendormate and pharmaceutical representatives resides on the UPHS Intranet at (Document is password protected. Copy-paste link in browser if clicking does not open it): https://pennmedaccess.uphs.upenn.edu/f5-w-687474703a2f2f75706873786e65742e757068732e7570656e6e2e656475$$/pahhome/pahpolicies/M15.pdf
- Contact for Vendormate at Penn:
Robert Fisher
Director, Materials Management
Hospital of the University of Pa
Tel: 215-662-4741
Email: Robert.Fisher@uphs.upenn.edu/ Robert.Fisher@pennmedicine.upenn.edu
A: Amendments to corporate-funded clinical trial and clinical research agreements may be initiated by creating a child record in the PennERA record of the original agreement (with the exception of “no-cost extensions”).
A no-cost extension is an amendment that (i) solely requests no-cost end date extensions, (ii) has no contractual language changes, and (iii) has a specific end date listed in the contract. If you want to request a no cost extension, to an existing corporate-funded clinical trial or clinical research agreement, please send an email to OCR Legal Services.
A: No, the other offices that handle contract drafting and negotiation are Penn Center for Innovation (PCI), Abramson Cancer Center (ACC), Office of Research Services (ORS). PCI handles agreements that are pre-clinical and animal studies (e.g., Research where informed consent IS NOT involved). ORS handles agreements that are federally funded, or partnered with a foundation or other non-profit organization. ACC handles corporate partnered agreements for the Abramson Cancer Center. OCR Legal handles corporate partnered clinical research agreements (eg., Research agreements where informed consent IS involved.