5701-0 Sole Source Determination~1.pdf

SOLE-SOURCE DETERMINATION MEMO

FOR SUPPLIES AND SERVICES

Date: September 13, 2023 Sole source number: S-44300-00008100

To: Kirk N. Rhoades, Designated Procurement Officer

DHS/OHA Office of Contracts & Procurement

Requestors: Ayo Ojebode, V/I Manager, PHL

Agency/division: Oregon Health Authority – Public Health, herein after referred to as “Agency”

Program/office: Center for Public Health Practice/Public Health Laboratory

Contract specialist: Jan Croeni

Agency Sole source rule: Sole source authority:

OHA OAR 137-047-0275 ORS 413.033

Estimated total contract value: $150,000 over a five-year period ($30,000/year) estimated expenditures.

Description of goods or services: Purchase annual Preventive Maintenance and

Service Agreements ($90,000) for PHL’s Two (2) ASSIST PLUS (AP) Electronic Pipettes and

Two (2) (AP) Base Units for the pipettes, Consumables and Supplies ($60,000) from

INTEGRA Biosciences Corporation over the upcoming five years.

1. Background:

This sole source determination request applies to the purchase of future annual

Preventive Maintenance and Service Agreements for two (2) each PHL-owned AP

Electronic Pipettes and Base Units ($90,000) plus Integra Biosciences Consumables and

Supplies ($60,000) required for the operation of INTEGRA’s fully automated electric pipettes purchased by PHL via PO 174537 February 2022. Electronic pipettes are used in all sections of the laboratory to measure and transfer a required volume of liquid within the sequencing, testing and/or screening processes. INTEGRA Biosciences Corporation is the sole manufacturer, distributor and vendor authorized to service INTEGRA ASSIST

PLUS Pipetting Robots, VOYAGER Adjustable Spacing Pipettes AND VIAFLO Electronic

Pipettes and required consumables/supplies. In order to ensure uninterrupted coverage and access to consumables and supplies needed to operate the pipettes, PHL requests approval this Sole Source Determination for five years with the option to extend for an additional five years (2033).

Describe the reasons the agency is seeking this procurement method:

The State of Oregon owns two (2) each of INTEGRA ASSIST PLUS Pipettes and Base

Units purchased from INTEGRA in February, 2022 through an Emergency Procurement while the State was under a Declared Emergency (Major Disaster Declaration Number

DR4499OR). PHL requires procurement authority to continue purchasing preventative maintenance, annual service agreements and the necessary consumables/supplies required for ongoing operation of the two pipettes and base units. A Sole Source

Determination for service and goods is requested for INTEGRA Biosciences, the sole manufacturer and proprietary owner of, and service provider for all INTEGRA instruments and operating supplies.

This is the most efficient and cost effective process to ensure continued use of

INTEGRA’s electronic pipettes since they are owned by the State and an investment of staff time and training has already been made to utilize these pipettes for screening and analyzing almost all specimens processed by the PHL. INTEGRA’s electronic pipetting robot streamlines routine pipetting tasks at an affordable price, automating repetitive tasks while eliminating physical strain, providing superior reproducibility and ensuring error-free processing.

Sole Source Letters from INTEGRA Biosciences accompany this Sole Source

Determination Memo as Attachment 2, state their position as proprietary owner, sole manufacturer/distributor and authorized vendor to provide services for the AP, VIAFLO and VOYAGER pipettes and consumables accompany required for the operation of the pipettes.

2. Prospective contractor/vendor:

Legal entity name: INTEGRA Biosciences Corporation

Address: 22 Friars Drive, Hudson, NH 03051

Contact person: Simon Seo, Sales Representative

Phone: 503.206.1400

Email: sse@integra-biosciences.com

Protests are due by 3:00 PM within seven calendar days after the first date the notice is posted on the OregonBuys website. Protests must be sent via OregonBuys.

Protests via telephone, fax, handwritten, or email will not be accepted.

Department of Human Services

Oregon Health Authority

Office of Contracts and Procurement

ATTN: Victoria Crosby

Address: 500 Summer Street E-03, Salem, OR 97301

Phone: 971. 372.9892 Fax: 503-378-4324

Email: Victoria.a.crosby@odhsoha.oregon.gov

Agency reserves the right to purchase additional goods and services from INTEGRA

Biosciences Corporation, including but not limited to, additional instruments, ancillary equipment, consumables and services.

3. Written findings of fact (market research):

The findings below must include factual information supporting the determination that meet the sole source requirement in statute.

Pursuant to ORS 279B.075, Agency must conduct market research that supports the assertion that there is only one source that can provide the goods or services.

Market research includes utilization of the internet, trade journals, agency vendor lists, professional organizations, studies, catalogs/industrial periodicals, vendor sources, yellow pages, etc.

For information technology contracts, any ownership or proprietary issues should be fully addressed with written documentation to support facts.

Agency must select at least one of the findings and prepare the determination as it specifically relates to the good or service being procured. More than one finding can be addressed. The findings are as follows:

Pursuant to ORS 279B.075 (2)(a): Provide findings supporting the determination that the efficient utilization of existing goods requires the acquisition of compatible goods or services from only one source.

1) The PHL purchased 2 AP Pipettes and 2 AP Base Units from INTEGRA via PO

174537 through an Emergency Procurement while the State was under a

Declared State of Emergency in February 2022; and

2) The PHL will need to continue to purchase preventative maintenance, annual service agreements, and consumables for the above referenced equipment.

or

Pursuant to ORS 279B.075 (2)(b): Provide findings supporting the determination that the goods or services required for the exchange of software or data with other public or private agencies are available from only one source. N/A or

Pursuant to ORS 279B.075 (2)(c): Provide findings supporting the determination that the goods or services are for use in a pilot or an experimental project. N/A or

Pursuant to ORS 279B.075 (2)(d): Any other findings that support the conclusion that the goods or services are available from only one source.

INTEGRA Biosciences Corporation provided supporting documentation that this company is the sole manufacturer, distributor and service provider of the INTEGRA

AP pipettes, base units and consumables. Internet research corroborates that

Goods and Services are not available on the open market from any retail vendor, as does a “Statewide Contract Search” on OregonBuys. This messaging is consistent with what is found on INTEGRA’s website. INTEGRA AP Pipette Tips and other consumables must be used with INTEGRA AP Pipettes in order to generate reliable results recognized by laboratory licensing, certifying and/or accrediting entities.

APPROVED:

By:

Kirk N. Rhoades, or acting DPO

ATTACHMENT 1

DETERMINATION OF BRAND NAME SPECIFICATION

Requestor: Ayo Ojebode, V/I Manager, PHL

Agency/division:

Oregon Health Authority/PHD, herein after referred to as

“Agency”

Program/office:

Center for Public Health Practice/Public Health Laboratory

Agency Brand name statute/rule: Brand name authority:

OHA ORS 279B.215 ORS 413.033

1. Brand name to be acquired:

Legal entity name: INTEGRA Biosciences Corporation

Address: 22 Friars Drive, Hudson, NH 03051

Contact person: Simon Seo, Sales Representative

Phone: 503.578.5800

Email: sse@integra-biosciences.com

2. Findings to satisfy required standards:

Use of a brand name specification is unlikely to encourage favoritism in the awarding of public contracts or substantially diminish competition for public contracts because: N/A or

Use of a brand name specification would result in substantial cost savings to the agency or the public because: N/A or

INTEGRA Biosciences Corporation is the proprietary owner, sole manufacturer and distributor of consumables and services for the ASSIST PLUS electronic multichannel automated pipetting instrument. INTEGRA has provided supporting documentation indicating that this company is the sole manufacturer and service provider of AP AP pipette. Internet research indicates that the Goods are not available on the open market from any retail vendor. A “Statewide Contract

Search” function and search on OregonBuys reflects that the Goods and Services are not available through any DAS price agreements. Sole source status is also posted on INTEGRA’s website. In order to ensure the integrity, reliability and results recognized by laboratory oversight organizations, all operating supplies must be manufactured by INTEGRA. In addition, INTEGRA maintains sole authority to provide service, preventive maintenance and repairs on the AP electronic multichannel pipettes in order for results to be considered valid.

or

The efficient utilization of existing goods requires the acquisition of compatible goods or services because: N/A

FINDINGS

The findings are accepted, adopted, and incorporated by reference herein.

Page 1 of 6 Revised July 2021 April 2023

Insurance Requirement Exhibit A

INSURANCE REQUIREMENTS:

Contractor shall obtain at Contractor’s expense the insurance specified in this section 4 prior to performing under this Contract. Contractor shall maintain such insurance in full force and at its own expense throughout the duration of this Contract, as required by any extended reporting period or continuous claims made coverage requirements, and all warranty periods that apply. Contractor shall obtain the following insurance from insurance companies or entities that are authorized to transact the business of insurance and issue coverage in the State of Oregon and that are acceptable to Agency. All coverage shall be primary and non-contributory with any other insurance and self-insurance, with the exception of

Professional Liability and Workers’ Compensation. Contractor shall pay for all deductibles, self-insured retention, and self-insurance, if any.

If Contractor maintains broader coverage and/or higher limits than the minimums shown in this insurance requirement exhibit, Agency requires and shall be entitled to the broader coverage and/or higher limits maintained by Contractor.

WORKERS’ COMPENSATION & EMPLOYERS’ LIABILITY

All employers, including Contractor, that employ subject workers, as defined in ORS 656.027, shall comply with ORS 656.017, and provide workers' compensation insurance coverage for those workers, unless they meet the requirement for an exemption under ORS 656.126(2). Contractor shall require and ensure that each of its subcontractors complies with these requirements. If Contractor is a subject employer, as defined in ORS 656.023, Contractor shall also obtain employers' liability insurance coverage with limits not less than $500,000 each accident.

If Contractor is an employer subject to any other state’s workers’ compensation law, Contactor shall provide workers’ compensation insurance coverage for its employees as required by applicable workers’ compensation laws including employers’ liability insurance coverage with limits not less than $500,000 and shall require and ensure that each of its out-of-state subcontractors complies with these requirements.

As applicable, Contractor/Recipient shall obtain coverage to discharge all responsibilities and liabilities that arise out of or relate to the Jones Act with limits of no less than $5,000,000 and/or the

Longshoremen’s and Harbor Workers’ Compensation Act.

COMMERCIAL GENERAL LIABILITY:

Contractor shall provide Commercial General Liability Insurance covering bodily injury and property damage in a form and with coverage that are satisfactory to the State. This insurance must include personal and advertising injury liability, products and completed operations, contractual liability coverage for the indemnity provided under this contract, and have no limitation of coverage to designated premises, project, or operation. Coverage must be written on an occurrence basis in an amount of not less than

$1,000,000.00 per occurrence and not less than $2,000,000.00 annual aggregate limit.

AUTOMOBILE LIABILITY INSURANCE:

Required Not required

Contractor shall provide Automobile Liability Insurance covering Contractor’s business use including coverage for all owned, non-owned, or hired vehicles with a combined single limit of not less than

$__________________ for bodily injury and property damage. This coverage may be written in combination with the Commercial General Liability Insurance (with separate limits for Commercial

Page 2 of 6 Revised July 2021 April 2023

General Liability and Automobile Liability). Use of personal automobile liability insurance coverage may be acceptable if evidence that the policy includes a business use endorsement is provided.

PROFESSIONAL LIABILITY:

Required Not required

Contractor shall provide Professional Liability covering any damages caused by an error, omission or any negligent acts related to the services to be provided under this Contract by the Contractor and Contractor’s subcontractors, agents, officers or employees in an amount not less than $_______________ per claim and not less than $__________________ annual aggregate limit.

If coverage is provided on a claims made basis, then either an extended reporting period of not less than

24 months shall be included in the Professional Liability insurance coverage, or the Contractor shall provide Continuous Claims Made coverage as stated below.

NETWORK SECURITY AND PRIVACY LIABILITY:

Required Not required

Contractor shall provide Network Security and Privacy Liability insurance for the duration of the contract and for the period of time in which Contractor (or its Business Associates or subcontractor(s)) maintains, possesses, stores, or has access to Agency or client data, whichever is longer, with a combined single limit of not less than $______________ per claim or incident. This insurance shall include coverage for third party claims and for losses, thefts, unauthorized disclosures, access or use of Agency or client data (which may include, but is not limited to, Personally Identifiable Information (“PII”), Payment Card Data and

Protected Health Information (“PHI”) in any format, including coverage for accidental loss, theft, unauthorized disclosure access or use of Agency data.

POLLUTION LIABILITY:

Required Not required

Contractor shall provide Pollution Liability Insurance covering Contractor’s or appropriate subcontractor’s liability for bodily injury, property damage and environmental damage resulting from sudden accidental and gradual pollution and related cleanup costs incurred by Contractor, all arising out of the Goods delivered or Services (including transportation risk) performed under this Contract is required. Combined single limit per occurrence not less than $__________________ and not less than

$____________________ annual aggregate limit.

An endorsement to the Commercial General Liability or Automobile Liability policy, covering

Contractor’s or subcontractor’ liability for bodily injury, property damage and environmental damage resulting from sudden accidental and gradual pollution and related clean-up cost incurred by the

Contractor that arise from the Goods delivered or Services (including transportation risk) performed by

Contractor under this Contract is also acceptable.

EXCESS/UMBRELLA INSURANCE:

A combination of primary and excess/umbrella insurance may be used to meet the required limits of insurance. When used, all of the primary and umbrella or excess policies shall provide all of the insurance coverages herein required, including, but not limited to, primary and non-contributory, additional insured, Self-Insured Retentions (SIRs), indemnity, and defense requirements. The umbrella or excess policies shall be provided on a true “following form” or broader coverage basis, with coverage at least as broad as provided on the underlying insurance. No insurance policies maintained by the Additional Insureds, Page 3 of 6 Revised July 2021 April 2023 whether primary or excess, and which also apply to a loss covered hereunder, shall be called upon to contribute to a loss until the Contractor’s primary and excess liability policies are exhausted.

If excess/umbrella insurance is used to meet the minimum insurance requirement, the Certificate of

Insurance must include a list of all policies that fall under the excess/umbrella insurance.

ADDITIONAL INSURED:

All liability insurance, except for Workers’ Compensation, Professional Liability, Pollution Liability and

Network Security and Privacy Liability (if applicable), required under this Contract must include an additional insured endorsement specifying the State of Oregon, its officers, employees, and agents as

Additional Insureds, but only with respect to Contractor’s activities to be performed under this contract.

Coverage shall be primary and non-contributory with any other activities to be performed under this

Grant.

Regarding Additional Insured status under the General Liability policy, we require additional insured status with respect to liability arising out of ongoing operations and completed operations, but only with respect to Contractor's activities to be performed under this Contract. The Additional Insured endorsement with respect to liability arising out of your ongoing operations must be on or at least as broad as ISO Form

CG 20 10 and the Additional Insured endorsement with respect to completed operations must be on or at least as broad as ISO form CG 20 37.

WAIVER OF SUBROGATION:

Contractor shall waive rights of subrogation which Contractor or any insurer of Contractor may acquire against the Agency or State of Oregon by virtue of the payment of any loss. Contractor will obtain any endorsement that may be necessary to affect this waiver of subrogation, but this provision applies regardless of whether or not the Agency has received a waiver of subrogation endorsement from the

Contractor or the Contractor’s insurer(s).

CONTINUOUS CLAIMS MADE COVERAGE:

If any of the required liability insurance is on a claims made basis and does not include an extended reporting period of at least 24 months, then Contractor shall maintain continuous claims made liability coverage, provided the effective date of the continuous claims made coverage is on or before the effective date of the Grant Agreement, for a minimum of 24 months following the later of:

(i) Contractor ’s completion and Agency’s acceptance of all Services required under the Contract, or

(ii) Agency or Contractor termination of this Contract, or

(iii) The expiration of all warranty periods provided under this Contract.

CERTIFICATE(S) AND PROOF OF INSURANCE:

Contractor shall provide to Agency Certificate(s) of Insurance for all required insurance before delivering any Goods and performing any Services required under this Contract. The Certificate(s) shall list the State of Oregon, its officers, employees and agents as a Certificate holder and as an endorsed Additional

Insured. The Certificate(s) shall also include all required endorsements or copies of the applicable policy language effecting coverage required by this Contract. If excess/umbrella insurance is used to meet the minimum insurance requirement, the Certificate of Insurance must include a list of all policies that fall under the excess/umbrella insurance. As proof of insurance Agency has the right to request copies of insurance policies and endorsements relating to the insurance requirements in this Contract.

Page 4 of 6 Revised July 2021 April 2023

NOTICE OF CHANGE OR CANCELLATION:

The Contractor or its insurer must provide at least 30 days’ written notice to Agency before cancellation of, material change to, potential exhaustion of aggregate limits of, or non-renewal of the required insurance coverage(s).

INSURANCE REQUIREMENT REVIEW:

Contractor agrees to periodic review of insurance requirements by Agency under this Contract and to provide updated requirements as mutually agreed upon by Contractor and Agency.

STATE ACCEPTANCE:

All insurance providers are subject to Agency acceptance. If requested by Agency, Contractor shall provide complete copies of insurance policies, endorsements, self-insurance documents and related insurance documents to Agency’s representatives responsible for verification of the insurance coverages required under this Section 4.

Additional Coverages That May Apply:

DIRECTORS, OFFICERS AND ORGANIZATION LIABILITY:

Required Not required

Contractor shall provide Directors, Officers and Organization Liability insurance covering the

Contractor’s Organization, Directors, Officers, and Trustees actual or alleged errors, omissions, negligent, or wrongful acts, including improper governance, employment practices and financial oversight -including improper oversight and/or use of use of grant funds and donor contributions which includes state or federal funds - with a combined single limit of not less than $_____________ per claim.

CRIME PROTECTION COVERAGE: EMPLOYEE DISHONESTY or FIDELITY BOND

Required Not required

Contractor shall provide Employee Third party Dishonesty or Fidelity Bond coverages for the loss of state-owned property by dishonest acts of an employee of the Contractor with coverage limits of not less than $ _______.

PHYSICAL ABUSE AND MOLESTATION INSURANCE COVERAGE:

Required Not required

Contractor shall provide Abuse and Molestation Insurance in a form and with coverage that are satisfactory to the State covering damages arising out of actual, perceived, or threatened physical abuse, mental injury, sexual molestation, negligent: hiring, employment, supervision, training, investigation, reporting to proper authorities, and retention of any person for whom the Contractor is responsible including but not limited to Contractor and Contractor’s employees and volunteers. Policy endorsement’s definition of an insured shall include the Contractor, and the Contractor’s employees and volunteers.

Coverage shall be written on an occurrence basis in an amount of not less than $____________ per occurrence and not less than $____________ annual aggregate. Coverage can be provided by a separate policy or as an endorsement to the commercial general liability or professional liability policies. The limits shall be exclusive to this required coverage. Incidents related to or arising out of physical abuse, mental injury, or sexual molestation, whether committed by one or more individuals, and irrespective of the number of incidents or injuries or the time period or area over which the incidents or injuries occur, shall be treated as a separate occurrence for each victim. Coverage shall include the cost of defense and the cost of defense shall be provided outside the coverage limit.

(DRONE) / UNMANNED AIRCRAFT SYSTEMS / UNMANNED AERIAL VEHICLE

LIABILITY:

Required Not required

Page 5 of 6 Revised July 2021 April 2023

Contractor shall provide Drone Liability Insurance covering bodily injury, property damage, and personal and advertising injury caused by owned and non-owned drones including the drone’s payload and/or dispensable loads in a form and with coverage that are satisfactory to the State. This insurance shall include premises liability, products and completed operations, contractual liability coverage for the indemnity provided under this contract, and have no limitation of coverage to designated premises, project, operation or territory of operation. Coverage shall be written on an occurrence basis in a combined single limit amount of not less than $________________ per occurrence.

AIRCRAFT LIABILITY

Required Not required

Contractor shall provide Aircraft Liability Insurance with a combined single limit for bodily injury and property damage liability including passengers (if carrying passengers other than crew members) of not less than $______________ per occurrence/aggregate.

AIR CARGO LIABILITY INSURANCE

Required Not required

Contractor shall provide Air cargo insurance covering loss of cargo in transit during the performance of this contract. Combined single limit per occurrence of not less than $________________ per occurrence.

AIRCRAFT AERIAL APPLICATION LIABILITY

Required Not required

Contractor shall provide Aircraft Aerial Application Liability Insurance covering claims arising from spraying operations. Coverage shall be not less than $__________________ combined single limit (alternate language if combined single limit cannot be provided: $____________ per person and $______________ per occurrence for bodily injury and $___________ for property damage). This insurance requirement can also be met with an endorsement to the Aircraft Liability coverage.

MOTOR CARRIER CARGO LIABILITY

Required Not required

Contractor shall provide Motor Truck Cargo Liability Insurance covering loss to cargo in transit during the performance of this contract. This coverage may be written in combination with the Commercial General

Liability Insurance (with separate limits). Combined single limit per occurrence of not less than

GARAGE LIABILITY

Required Not required

Contractor shall provide Garage Liability Coverage for Garage Operations. Coverage shall include Garage

Keepers legal liability for autos left for service or repair and be not less than $ ____________ combined single limit.

GARAGE KEEPERS LEGAL LIABILITY

Required Not required

Contractor shall provide Garage Keepers´ Legal Liability Coverage for autos left for service, repair, storage, or safekeeping, with a combined single limit of not less than $__________________ per location.

BAILEE’S COVERAGE

Required Not required

Contractor shall provide Bailee’s Customers Property Insurance covering any and all State property left in the care, custody, or control of the Contractor. Coverage shall include valuable papers, including but not

Page 6 of 6 Revised July 2021 April 2023 limited to microfilm. Coverage shall be written on an occurrence basis with a combined single limit per occurrence of not less than $ ______________ for each site or location.

MARINE PROTECTION LIABILITY

Required Not required

Contractor shall provide Marine Protection and Indemnity Coverage with a combined single limit per occurrence of not less than $ ______.