Pharmaceutical RFI Opportunity

Experience needed in one or more of the following areas:

1. Drafting and responding to cease and desist letters and filing and defending US trademark opposition and cancellation actions in connection with cosmetics, medical devices and pharmaceutical products, including conducting in-depth trademark case law research to support responses to cease and desist letters
2. Conducting full U.S. trademark searches and analyses in connection with cosmetics, medical devices and pharmaceutical products
3. Drafting UDRP complaints against 3rd party domain names

Experience needed in one or more of the following areas:

1. Company is developing an Company-owned and -operated aesthetics research facility in California and will conduct regulated clinical studies for medical devices and pharmaceuticals. have questions related to:
   1. Corporate practice of medicine requirements in California.
   2. What services can Company employees perform (independently or under the supervision of licensed staff from a professional corporation)?
   3. What services must be performed by licensed staff from a professional corporation contracted by Company?
   4. Facility licensure requirements.
   5. Applicability of HIPAA and California privacy laws to research that will be conducted at the facility;
   6. Company employee participation in research at the facility;
   7. Informed consent and recruitment; and
   8. Separation between sponsor and study site roles.

Experience needed in one or more of the following areas:

1. Decentralized trial considerations
2. Trial acceleration tactics (shortcuts to be taken in drug development to cut; and development timelines to market)
3. Diversity in clinical trials

Description of need in this area:

Company needs to reduce our ~100 procurement agreement templates into separate clauses (with consistency across templates as much as possible) in order to load them into a CLM tool for future use. The project will require identifying and comparing clauses across templates and determining which should be used and identifying missing clauses.  Expect project to kick off in September and be completed within ~2-3 months.

Description of need in this area:

Counsel for general real estate transactions and real estate-related due diligence reviews (jurisdictions TBD based on deal/project).

Description of need in this area:

General environmental counsel (federal and state), superfund counsel, OSHA counsel.

Description of need in this area:

Privacy and Digital advertising – guidance on:

1. the use of first- and second-party data
2. adapting to recent changes in Google’s use of first party cookies.

Description of need in this area:

Expertise in state and federal government healthcare policy, legislation and regulation, including government contracts, know-how and prior government job experience.

Experience needed in one or more of the following areas:

1. Analysis of FDA Requirements for a Phase II Platform Study: (1) What is required for a Phase II platform vs. a Phase III Platform?; (2) What are the risks associated with doing a PHII and converting to a registrational PHIII?

2. FDA’s view on registrational PHII open label studies: When can these be used as support for an NDA/BLA and when does FDA require a closed/masked study, and are there any exceptions? What may be the ramifications of doing an open label when FDA has requested a blinded/masked study?

3. Examples of where sponsors have successfully re-used existing Data to save on developmental timelines (Safet, Tox, etc.), and gone straight to registrational trials with a different product. (i.e. a follow-on product with a different active ingredient was able to utilize past studies as some properties of the new product was similar/comparable to the original product)

Description of need in this area:

We are looking for experienced counsel (located anywhere) to assist with product liability, auto liability, and general commercial matters. While we don’t have a specific project to pitch work for, we would be interested in having firms present a case study on a relevant example matter they have worked on through completion. This will help us assess how they handle cases and whether they could be a good fit for Company. We can be available to discuss with the firm beforehand to align on what to include in the case study.

Description of need in this area:

Interested in seeking talent with established and strategic experience in prosecuting small molecule patent applications. Experience with supporting Fortune 500 and mid-tier pharmaceutical companies is beneficial.

Description of need in this area:

Interested in seeking talent with established and strategic experience in performing IP due diligence evaluations in connection with the acquisition of pharmaceutical, biopharmaceutical, or medical device companies or products. Experience with supporting Fortune 500 and mid-tier pharmaceutical companies is beneficial.