We have invested time and thought in our facility and services; a thoughtful legal strategy helps us protect those investments

Mutual Two Way Confidentiality Agreement

Both PII and our customers have confidential information to protect. Before any project discussions or site visits, a two way CDA is signed. Typically, this process takes less than a week.

Short Form Legal Terms for Work Scopes

Initially, once a work scope has been agreed upon, PII will attach legal terms for the project to start. These terms usually contain provisions for confidentiality, intellectual property, warranties, termination, indemnification and governing law. Short form legal terms allow PII to start work for clients before negotiating a full Master Services Agreement.

Master Services Agreement

Whenever our client desires, a Master Services Agreement can be put into place to address the legal terms applicable to our services. Many of the legal terms can come from short form legal terms. All future work scopes can be carried out under this MSA. Quality issues are addressed under a separate Master Quality Agreement agreed to by the PII QA department and our customers. The benefit of a MSA is in allowing PII to serve its clients with an even faster turn around as contracts do not have to go through a separate legal review for every work scope.

Commercial Supply Agreement (CSA)

As an on-going relationship develops between PII and our clients, commercial manufacturing is a governed in a separate document from initial work scopes or MSA. Again, the legal terms previously negotiated in the prior agreements form the basis of the CSA. This ensures continuity between agreements.

Intellectual Property (IP) Strategy

PII is a formulation and drug delivery development company and may develop process or formulation improvements that are innovative and patentable. We recognize that it is essential to protect innovation where it occurs, as well as our client’s intellectual property. If the IP developments relate exclusively to our client’s compounds, our client will own the IP. Otherwise, when the IP developments have more general application to pharmaceutical products, PII will license on a royalty-free basis to our client the right to use the IP developments for the product for which PII provided its services.