A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301

This is a phase 3b, prospective, sequential, open-label study designed to evaluate the
efficacy, safety, and health economic benefits of intraoperative local wound infiltration
with SKY0402 (bupivacaine liposome extended-release injectable suspension) compared with
postsurgical administration of standardized intravenous (IV) morphine sulfate for
postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.

Inclusion Criteria:

- Male or female, 18 years of age and older.

- Patients scheduled to undergo open segmental colectomy with planned primary
anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse
colon, left hemicolectomy, or sigmoidectomy.

- Ability to provide informed consent, adhere to study visit schedule, and complete all
study assessments.

Exclusion Criteria:

- Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance
to any local anesthetic, opioid, or propofol.

- Patients who abuse alcohol or other drug substance.

- Patients with severe hepatic impairment.

- Patients currently pregnant or who may become pregnant during the course of the
study.

- Patients with any psychiatric psychological, or other condition that the Investigator
feels may make the patient an inappropriate candidate for this clinical study.

- Patients who have participated in a SKY0402 (EXPAREL) study within the last 30 days.

- Patients who have received any investigational drug within 30 days prior to study
drug administration, or planned administration of another investigational product or
procedure during the patient's participation in this study.

In addition, the patient will be ineligible if he or she meets the following criteria
during surgery:

- Patients with unplanned multiple segmental resections of large intestine.

- Patients who have unplanned, temporary or permanent colostomies placed.

- Patients who receive intraoperative administration of opioids (other than fentanyl or
analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.

- Patients who receive Entereg(R).