SK biotek IP PROTECTION POLICY

1. Purpose
The purpose of this policy is to describe the Intellectual Property (IP) Protection policy at SK biotek Ireland.

2. Scope
This policy is applicable to SK biotek Ireland customer Intellectual Property. This policy does not apply to any SK biotek generated IP arising from an improved process.

3. Policy
3.1. General
SK biotek Ireland is a CDMO that operates to the very highest manufacturing and commercial standards.  It recognises that Customers are protective of their products and intellectual property. To that end this policy outlines the protections that are in place to ensure that the Customer’s intellectual property is protected while in the possession of SK biotek Ireland and is used only in the manner set out in legally binding agreements.
The following procedure details Intellectual Property Protection measures through all stages of product life-cycle at SK biotek Ireland.

3.2. Request For Proposal (RFP)
3.2.1. Intellectual Property shared by a customer with SK biotek Ireland for RFP purposes is protected by negotiated, legally binding, commercial agreements and customer confidentiality disclosure agreements (CDA).
3.2.2. Customer IP is shared within SK biotek Ireland on a need to know basis only. RFP/new project proposals are developed by a core team of Marketing and Technical personnel.
3.2.3. All information relating to a project is stored on a secure controlled access sharepoint site.
3.2.4. If an RFP does not progress to project stage all documentation relating to this RFP is deleted as per the applicable CDA.

3.3. Project development / Commercial manufacturing
3.3.1. Development of a project to commercial manufacturing involves sharing customer information with a wider variety of teams on site. SK biotek Ireland limits access to information to a defined audience that has an appropriate and legitimate need for the information in order to prevent improper disclosures
3.3.1.1. All personnel have confidentiality clauses in employee contracts.
3.3.1.2. All personnel receive training on IP protection.
3.3.1.3. Only SK biotek Ireland email/IM is used for employee communication.

3.3.2. IT Controls
SK biotek Ireland maintains information to ensure that it can be easily retrieved and to ensure that the information’s authenticity, reliability and readability is protected. As such, SK biotek Ireland encourages the use of electronic information whenever practical.
3.3.2.1. SK biotek Ireland maintains a highly secure IT network, with a dedicated, onsite IM department.
3.3.2.2. All digital/electronic resources are configured to enable appropriate security.
3.3.2.3. All personal computers/laptops are fully access controlled with secure, confidential and complex passwords.
3.3.2.4. The IM department manage the process of establishing, tracking, reviewing and disabling identities for all digital/ electronic resources.
3.3.2.5. All GMP computer equipment is validated, with controlled user access, individual password protection and have full audit trails.
3.3.2.6. A clean desk policy is in operation at SK biotek Ireland, with the aim of protecting customer information through ensuring that laptops and other portable data storage devices are stored appropriately in a secure location.

3.3.3. Information/Documentation Controls
3.3.3.1. SK biotek Ireland retains information only for the period of time necessary to meeting business, legal and regulatory requirements.
3.3.3.2. Information and records containing customer IP must be labelled as ‘confidential’. This label is placed in the footer of a hard copy or digital information or record.
3.3.3.3. Information is controlled in order to limit access to an audience defined by the author.
3.3.3.4. All users are responsible for protecting confidentiality of information and preventing unauthorized disclosure.

3.3.3.5. Paper Records
3.3.3.5.1. Once completed, an electronic copy of all paper QC batch records and manufacturing batch records (MBR) is taken and saved to a secure database.
3.3.3.5.2. All paper GMP records e.g. QC batch records, MBRs and validation documentation are stored offsite at a SK biotek Ireland preferred storage facility. A quality agreement is in place with the storage facility and routine audits are performed of the storage facility to ensure compliance with the quality agreement.
3.3.3.5.3. All paper information is disposed of in clearly marked designated confidential waste bins.

3.3.4. Physical Security
3.3.4.1. A security presence is maintained at SK biotek Ireland on a 24/7, 365 days per year basis.
3.3.4.2. All access to the campus is controlled by security through an electronic access control system. This controls the movement of people through critical entry /exit locations.
3.3.4.3. A fully monitored security and fire alarm system is in operation at SK biotek Ireland.

3.4. Product Discontinuation
3.4.1. SK biotek Ireland disposes of information using secured and approved methods once the retention period has been satisfied and any applicable holds have been lifted.
3.4.2. For discontinued products batch record paperwork is archived for 9 years after the date of manufacture.
3.4.3. Retain samples of intermediates and APIs are kept in controlled storage for three years post expiration date of the material
3.4.4. Electronic records are archived on the SK biotek Ireland secure network

4. Definitions

5. References
1. C-SEC-POL-001 Clean desk Policy
2. SEC-SOP-GEN-009 Access Control – Equipment and Procedures

6. Document History