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Basic Contracting Guidelines

Basic Contracting Guidelines
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Easy Processing through OGC

If review by the Office of General Counsel will be necessary, get us involved early -- all legal work can be completed well before protocols are even approved.

 Use of Transmittal Forms

Transmittal froms are required in some circumstances. Please review the UTS125 Processing Intellectual Property Agreements and UTS125 At-A Glance to determine whether a transmittal form will be required for your agreement.

 Use of Forms B and D requires that you be sensitive to when changes to our standard form agreement (Form B) or a company universal agreement (Form D) are non-substantive.

  • Call/fax/email any changes related to the four IP sections for quick feedback on whether a change is substantive.
  • If you have to use Form F, there should be no extra delay if you contact us early in the process.

Turnaround time for direct inquiries is usually within a few days, if not the same day. If you need an immediate answer, please advise us so we can arrange to meet your deadline.

 General Drafting Tips

Always start with the appropriate standard or company universal agreement. Never offer one company's agreement to another company as a first draft.

  • Tell this to your investigators.
  • If you will have to work from the company's agreement form, use our standard clauses and checklists to evaluate the company's proposal.

Carefully consider who the parties are, who should sign for each, and be sure that the obligations undertaken in the agreement are consistent with the ability of the parties to fulfill them.

  • PI's are not parties to the agreement, so they should not be referred to as though they were. If a Sponsor is particularly troubled by this, offer language like the following:

    "Institution represents that the Principal Investigator and all other investigators may perform services hereunder are its employees and shall abide by the terms and conditions of this Agreement as if each were a party hereto."

  • Third party agreements pose several porblems with respect to who signs them and who is obligated by them. The parties to an agreement cannot bind a third party to do anything.

Be consistent throughout the agreement with defined terms, outline levels, and incorporation of clauses from other agreements. Always conform "borrowed" terms to your agreement's definitions.

 Remove any paragraphs that are not relevant to your transaction.

 Avoid implied provisions - make them explicit instead.

  • Example: If Sponsor only agrees to pay patent costs with respect to jointly owned inventions, it is impled that Sponsor will not pay such costs with respect to University solely owned inventions. Make it clear that we expect both.
  • Example: "If Institution has not received Sponsor's comments within sixty (60) days, it is agreed that approval for publication is granted." This implies that Sponsor could withhold approval for publication. Make it clear that we must have final editorial control over publications and Sponsor has no right to withhold consent or approval.

Avoid repetition - do not say the same thing or address the same issues in two different places.

 Avoid pronouns - use the parties' names or defined terms as references rather than pronouns (him, his, it, its, them, their) unless the party to whom a pronoun refers is clear from the context.

 Recitals

Recitals are very valuable, especially with an unusual deal. They set the stage and fill in background information.

 Drafting hint: Imagine that you are someone unrelated to and with no knowledge of the deal, and that you are charged with making sense of the transaction two years later. Write the recitals (and indeed, the whole agreement) so that a person could read them one time and understand the reason for the contract and what it is going to do.

 Alternative Dispute Resolution

Alternative Dispute Resolution (ADR) language is usually acceptable. If the Sponsor has included an arbitration clause, it would be helpful to insert language like, "appropriate method of alternative dispute resolution, including, without limitation, arbitration..." to expand the possibilities to include escalation within the internal hierarchies of the parties (elevating the dispute to less interested persons to resolve), mediation, etc. Alternatively, you may counter-offer with one of our standard clauses.

 Debarment Statement

One of the statements below regarding debarment fulfills the regulatory requirements and is acceptable without further review by OGC:

           INSTITUTION represents that it has never been, and to the best of its knowledge after reasonable inquiry, its Principal Investigator or any other individual who will be rendering services under this Agreement, has never been: 1) debarred, or 2) convicted of a crime for which a paerson can be debarred, under Section 306(a) or 306(b) of the Generic Drug Enforcement Act of 1992 ("Section 306(a) or (b)"). INSTITUTION represents that it has never been, and to the best of its knowledge after reasonable inquiry, its Principal Investigator or any other individual who will be rendering services under this Agreement, has never been: 1) threatened to be debarred, or 2) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b). INSTITUTION agrees that it will promptly notify SPONSOR in the event of any such debarment, conviction, threat, or indictment. The terms of the preceding sentence shall survive the termination or expiration of this Agreement for a period of three (3) years. 

OR

           INSTITUTION certifies and Principal Investigaor certifies to INSTITUTION that it has never been, and to the best of its knowledge after reasonable inquiry, its Principal Investigator or any other individual who will be rendering services under this Agreement has never been: 1) debarred, or 2) convicted of a crime for which a person can be debarred, under Section 306(a) or 306(b) of the Generic Drug Enforcement Act of 1992 ("Section 306(a) or (b)"). INSTITUTION certifies and Principal Investigator certifies to INSTITUTION that it has never been, and to the best of its knowledge after reasonable inquiry, its Principal Investigator or any other individual who will be rendering services under this Agreement has never been: 1) threatened to be debarred, or 2) indicted for a crime or otherwise engaged in coduct for which a person can be debarred, under Section 306(a) or (b). INSTITUTION agrees that it will promptly notify SPONSOR in the event of any such debarment, conviction, threat, or indictment. The terms of the preceding sentence shall survive the termination or expiration of this Agreement for a period of three (3) years.

   

Disclaimer: The materials on this website do not constitute legal advice. You should consult with an attorney before acting on or conveying any interpretation of these materials.

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