Women working in the lab

IP Policy – Korea

1.) Purpose

The purpose of this policy is to describe the intellectual property protection policy at SK biotek Co., Ltd. (“IP Protection Policy”).

2.) Scope

This IP Protection Policy is applicable to the any intellectual property of SK biotek Co., Ltd.’s customers, any intellectual property generated by SK biotek Co. Ltd (“SKBT”) or affiliate of SKBT arising from an improved process of SKBT’s background IP or general applicability to SKBT’s business, such IP vesting in SKBT or SKBT’s affiliate solely.

3.) Policy

  • 3.1 GeneralSKBT is a CDMO that operates to the very highest manufacturing, quality and commercial standards. It recognizes that it is imperative that customers protect their products and intellectual property. To that end this IP Protection Policy outlines the protections that are in place to ensure that the customer’s intellectual property is protected while in the possession of licensed to of SKBT and is used solely in the manner agreed between the customer and SKBT as set out in legally binding agreements.The following procedure details IP Protection measures through all stages of product life-cycle at SKBT.
  • 3.2 At the stage of Request For Proposal (“RFP”)3.2.1. Intellectual property (“IP”) shared by a customer with SKBT for RFP purposes is protected by negotiated, legally binding, commercial agreements and confidentiality disclosure agreements (“CDA”).3.2.2. Customer IP is shared within SKBT on a need to know basis only. RFP and/or new project proposals are developed by a core team of marketing and project management personnel.3.2.3. All information relating to a project (“Information”) is stored on a secure controlled access SharePoint site.3.2.4. If a RFP does not progress to project stage, all documentation relating to this RFP is deleted or returned to the customer as per the applicable CDA.
  • 3.3 At the stage of Project Development, Commercial Manufacturing3.3.1. Development of a project to commercial manufacturing involves sharing Information with a wider variety of teams on site. SKBT limits access to Information to a defined audience that has an appropriate and legitimate need to access the Information in order to manufacture the customer product and to prevent improper disclosures.3.3.1.1. All personnel have signed up to strict confidentiality clauses in confidentiality agreements. Personnel are aware of the sanctions, up to and including termination for gross misconduct, if such a breach were to occur.3.3.1.2. All personnel are aware of the possible legal sanctions should a breach occur.3.3.1.3. All contractors have signed up to strict confidentiality clauses in their agreements with SKBT and are aware of the sanctions, up to and including termination for material breach of those agreements should a breach occur.3.3.1.4. Only SKBT email is used for employee communication.3.3.1.5. SKBT has and will continue to develop a culture of customer IP Protection as a key value of the business.
  • 3.3.2. IT Controls3.3.2.1. SKBT maintains information to ensure that it can be easily retrieved and to ensure that the information’s authenticity, reliability and readability it protected. As such, SKBT encourages the use of electronic information whenever practical.3.3.2.2. SKBT maintains a highly secure IT network, with a dedicated, identity access management department (“IAM department”).3.3.2.3. All digital/electronic resources are configured to enable appropriate security.3.3.2.4. All personal computers/laptops are fully access controlled with secure, confidential and complex passwords.3.3.2.5. IAM department manage the process of establishing, tracking, reviewing and disabling identities for all digital/electronic resources.3.3.2.6. All CGMP computer equipment is validated, with controlled user access, individual password protection and has full audit trails.3.3.2.7. A clean desk policy is in operation at SKBT, with the aim of protecting Information through ensuring that laptops and other portable data storage devices are stored appropriately in a secure location.
  • 3.3.3. Information / Document Controls3.3.3.1. SKBT retains Information only for the period of time necessary to meeting business, legal and regulatory requirements as outlined in SKBT policy.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, the author being the person or people key to the product manufacture.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 is taken and saved to a secure database.

3.3.3.5.2. All paper CGMP records (e.g. QC batch records, manufacturing batch records and validation documentation) are stored on site at SKBT storage facility.

3.3.3.5.3. All paper information is disposed of in clearly marked designated confidential waste bins.

  • 3.3.4 Physical Security Controls3.3.4.1. A security presence is maintained at SKBT on a 24/7, 365 days per year basis.3.3.4.2. All access to the SKBT site is controlled by security through an electronic access control system. This controls the movement of people through critical entry/exit locations. It also ensures that only those people who need access to certain sensitive locations can access to such locations.3.3.4.3. A fully monitored and audited security and fire alarm system is in operation at SKBT.
  • 3.4 In case of Product Discontinuation3.4.1. SKBT 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. SKBT can arrange to have the confidential information returned to the customer at the end of the relevant retention period, at the customer’s request.3.4.3. For discontinued products batch record paperwork is archived for 7 years (9 years for API products) after the date of manufacture.3.4.4. Electronic records are archived on SKBT secure network3.4.5. All of the above is subject to any legal or regulatory obligation SKBT may be obliged to maintain records outside of the normal retention period but any deviation from the normal retention period will be for that/those purposes only.
  • 4. Definitions4.1 Intellectual Property means tangible or intangible results of research, development, teaching, or other intellectual activity. IP allows creativity and innovation to be captured and owned in the same way as physical property can be owned. IP includes individually and collectively all technical innovations, inventions, improvements, and/or discoveries, information, writings and software, whether or not patentable or otherwise susceptible to intellectual property protection, including know-how, process, technology and materials in their tangible form.
  • 5. References5.1 IV-Information-05. Guidelines on Document Security
    5.2 MS G002 Document Management Procedure