Exhibit
10.9


 


Page 1 of 14 


 


Quality
Agreement


 


between


 


Biofrontera
Incorporated


hereinafter
referred to as “Biofrontera”


 


and


 


Biofrontera
Pharma GmbH


hereinafter
referred to as “Pharma”


 




    	Confidential



    	Page 2 of 14



    

 


APPROVALS


 


The
information contained in this Agreement of Responsibilities has been reviewed and approved by the following individuals:


 


	Approved
    By:	 	Effective
    Date
	 	 	 
	Biofrontera
    Incorporated:	 	 
	 	 	 
	/s/
    Monica Tamborini	 	11/1/2016
	[Monica
                                            Tamborini]

    [COO]

    Biofrontera
    Inc.
	 	(Date
    Signed)
	 	 	 
	Biofrontera
    Incorporated:	 	 
	 	 	 
	/s/
    Darrell T. Lowman	 	11/01/2016
	[Darrell
                                            T. Lowman]

    [Quality
    Assurance Director]

    Biofrontera
    Inc.
	 	(Date
    Signed)
	 	 	 
	Biofrontera
    Pharma GmbH	 	 
	 	 	 
	/s/
    Hermann Lübbert	 	27-10-16
	[Hermann
                                            Lübbert]

    [CEO]

    Biofrontera
    Pharma GmbH
	 	(Date
    Signed)
	 	 	 
	Biofrontera
    Pharma GmbH	 	 
	 	 	 
	/s/
    Wiebke Meyer-Wendt	 	13
    Oct. 2016
	[Wiebke
                                            Meyer-Wendt]

    [Director
    Quality Management]

    Biofrontera
    Pharma GmbH
	 	(Date
    Signed)


 




    	Confidential



    	Page 3 of 14



    

 


TABLE
OF CONTENTS


 


	1.	Recital	4
	2.	Purpose
    and Scope of the Quality Agreement	4
	3.	Terms
    of Agreement	4
	4.	Abbreviations	5
	5.	Product
    and Services	5
	6.	Quality
    Systems 	6
	7.	Documentation
    Control	7
	8.	Purchasing
    and Material Control System 	7
	9.	Laboratory
    Testing and Quality Controls System	8
	10.	Facility
    and Equipment Controls	9
	11.	Production
    and Process Controls	9
	12.	Control
    of Non-Conforming Product, Disposition and Rework	9
	13.	Corrective
    and Preventive Action	10
	14.	Handling,
    Storage, Distribution, Installation and Servicing	10
	15.	Shipment	10
	16.	Records	11
	17.	Complaints
    and Pharmacovigilance	11
	18.	Annual
    Product Reviews and Annual Reports	11
	19.	Company
    Contacts	12
	Attachment
    I – Product(s)	13
	Attachment
    II – Controlled documents to be provided to each other	14


 


 




    	Confidential



    	Page 4 of 14



    

 


	1.	Recital


 


The
Parties to this quality agreement are also Parties to a License and Supply Agreement (LSA) according to which Pharma grants a license
to Biofrontera for the import, distribution and marketing in the USA of the drug product and medical device listed in Attachment 1.


 


According
to the agreement, Pharma is obliged to deliver Products of the quality and according to the specifications agreed upon with the FDA in
the respective approvals.


 


Approval
Holder of the drug / device combination is Biofrontera Bioscience GmbH, which also owns all IP on the drug. IP on the device is owned
by Pharma. Biofrontera Bioscience GmbH has provided Pharma with an exclusive license to manufacture and market the Products, including
the right for sublicensing. In this role, Pharma has granted the license to Biofrontera, which forms the basis of this Quality Agreement.
All commercial aspects are ruled by the License and Supply Agreement between the Parties to this Quality Agreement.


 


Biofrontera
is obliged to market and distribute the product according to label / approval and perform some local activities on behalf of the Approval
Holder. For instance, Biofrontera is responsible for ensuring that Ameluz is stored and transported at the temperature defined in the
Prescribing Information and sold exclusively to customers qualified to receive a drug product or medical device.


 


	2.	Purpose
    and Scope of the Quality Agreement


 


	 	2.1.	Purpose
    of this agreement is to define and document quality and regulatory responsibilities including, but not limited to manufacturing,
    packaging, labeling, complaints, change control and any applicable requirements. 
	 	 	 
	 	2.2.	This
    agreement does not define the forecasting, ordering, delivery, or pricing requirements for either party. This agreement does not
    define the specifications for the products or services covered.
	 	 	 
	 	2.3.	The
    scope of the quality agreement applies to the products listed in Attachment 1.
	 	 	 
	 	2.4.	This
    Agreement supersedes any previous written quality agreement between the parties.
	 	 	 
	 	2.5.	The
    effective date of this agreement shall be the date of the last signature.


 


	3.	Terms
    of Agreement


 


	 	3.1.	It
    is acknowledged that this will be a continuously evolving process, requiring review at a minimum, for each additional new Product
    whose manufacturing, testing, packaging, distribution and/or marketing responsibilities is shared between Biofrontera and Pharma.
    
	 	 	 
	 	3.2.	Failure
    to perform all or part of the Agreement may result in discontinuation of services or termination of contract by the party which is
    not in default, if the issue is not corrected with a reasonably agreed timeframe. 
	 	 	 
	 	3.3.	If
    material differences exist between this Agreement and Biofrontera’s Standard Operating Procedures, this Agreement shall control
    but Biofrontera shall notify Pharma of such differences and the Parties agree to make good faith efforts to resolve such material
    differences. Attachment 2 contains a list of controlled documents which Biofrontera and Pharma shall provide to each other.


 




    	Confidential



    	Page 5 of 14



    

 


	4.	Abbreviations




 


	 	ADE
    / AE 	Adverse
    Drug Event / Adverse Event
	 	APR	Annual
    Product Review
	 	CAPA	Corrective/Preventive
    Action
	 	CFR	Code
    of Federal Regulations
	 	FDA	Food
    and Drug Administration
	 	GMP	Good
    Manufacturing Practice
	 	HVAC	Heating,
    Ventilation and Air Conditioning
	 	LSA	License
    and Supply Agreement
	 	MDR	Medical
    Device Reporting
	 	OPDP	Office
    of Prescription Drug Promotion
	 	PDMA	Prescription
    Drug Marketing Act of 1987
	 	QMS	Quality
    Management System
	 	SCAR
    	Supplier
    Corrective Action Request


 


	5.	Product
    and Services


 


	 	5.1.	Product
    Classification(s) [Check all that apply]


 


☒
Drug        ☒ Medical        ☐
Device      ☐ Cosmetic           ☐ Other


 


	 	5.2.	Services
    [Check all that apply]


 


Biofrontera
Inc.


 





	 	☐	Owner/Specification
    Developer
	 	☐	Relabeler
    or Repackager
	 	☒	Distributor
	 	☐	Contract
    manufacturer
	 	☐	Contract
    sterilizer
	 	☐	Initial
    Importer
	 	☒	Importer
    of Drug Product
	 	☒	Licensee


 


Biofrontera
Pharma (also representing Biofrontera Bioscience GmbH)


 





	 	☒	Owner/Specification
    Developer
	 	☐ 	Relabeler
    or Repackager
	 	☐	Distributor
	 	☒	Contract
    manufacturer
	 	☐	Contract
    sterilizer
	 	☐	Initial
    Importer
	 	☒	Importer
    of Medical Device
	 	☒	Licenser
    (on behalf of NDA sponsor, Biofrontera Bioscience GmbH)


 


	 	5.3.	Regulatory/Quality
    control


 


☒
21 CFR 820, QSR (Quality System Regulations)


☒ 21
CFR 210, 211, cGMP (Current Good Manufacturing Practices)


 




    	Confidential



    	Page 6 of 14



    

 


	6.	Quality
    Systems


 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	6.1.
    	 	☒	 	☒	 	Quality
    System - A quality system shall be established, documented and maintained as a means of ensuring that Product conforms to specifications
	6.2.
    	 	☒	 	☒	 	Quality
    Manual that includes a quality policy shall be established and both parties shall ensure that the policy is understood, implemented
    and maintained at all level of the organization.
	6.3.
    	 	☒	 	☒	 	Quality
    Audit – Establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance
    with the established cGMP and QS requirements.
	6.3.1.
    	 	☐	 	☒	 	Reserves
    the right to audit Pharma premises and all documentation used in the manufacturing, packaging and testing of the Product during normal
    business hours with reasonable written notice and causing minimum disruption to Pharma operations.
	5.3.2	 	☒	 	☐	 	Reserves
    the right to audit BIOFRONTERA premises and all documentation related to marketing and distribution of products in the US during
    normal business hours with reasonable written notice and causing minimum disruption to BIOFRONTERA operations.
	6.3.2.
    	 	☒		☒	 	Provide
    a written detailed report of audit observations and conclusions.
	6.3.3.
    	 	☒	 	☒	 	Provide
    a written response to audit observations and conclusions within thirty (30) days of receipt of a written audit report.
	6.3.4.
    	 	☒	 	☒	 	Provide,
    as appropriate, proof of corrective/preventive action(s) implemented to address audit observations
	6.4.
    	 	☐	 	☒	 	Recall,
    Removal - Maintain Product records including lot and serial numbers, as applicable and shipping information to ensure traceability
    in the event a recall or market withdrawal is required. Support Stop Shipment Notification, Notice of Recall, and Replacement log.
	6.4.1.
    	 	☒	 	☐	 	Primary
    responsibility for recall activities including but not limited to providing Notice of Recall Product Recall, Recall Coordinator,
    FDA recall submission, periodic recall status reporting, recall termination and closing. 
	6.5.
    	 	☒	 	☒	 	Qualifications
                                            and Training - Procedures shall be established to ensure that all personnel have adequate
                                            combination of education, experience and documented training to perform job functions.

    Training
    shall be conducted and documented.

	6.6.
    	 	☒	 	☒	 	Regulatory
    Agency Inspections - Inform the other Party within one (1) business day in case of warning letters and major quality issues that
    may impact the Product and represent a risk for the patient or the user.
	6.7.
    	 	☒	 	☒	 	Regulatory
    Agency Communications - Provide copies (redacted, if required) of regulatory agency 483s, Warning Letters and other Notices relating
    to its activities associated with the product.
	6.8.
    	 	☒		☒	 	Establishment
    Registration and Listing - Maintain current FDA Establishment Registration(s) and listing for all applicable activities.
	6.9.
    	 	☐	 	☒	 	State
    Licensing – Maintain state licenses for the distribution of drug products and medical devices as applicable and fulfil
    all state reporting obligations.
	6.10.
    	 	☐	 	☒	 	Customer
    Qualification - Implement processes to ensure that products are distributed to qualified customers only
	6.11.
    	 	☐	 	☒	 	Drug
    Sample Distribution – Implement processes to ensure that drug samples are distributed according to the requirements dictated
    in the Prescription Drug Marketing Act (PDMA). Compliance with PDMA requirements for documentation and reporting to FDA and the States
    where applicable. 
	6.12.
    	 	☐	 	☒	 	Sunshine
    Act – fulfill all obligations of the Physician Payments Sunshine Act, including appropriate documentation and reporting.
	6.13.
    	 	☐	 	☒	 	Compliance
    with all federal and state laws related to the distribution of drug products and medical devices.


 




    	Confidential



    	Page 7 of 14



    

 


	7.	Documentation
    Control


 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	7.1	 	☒	 	☒	 	Implement
    and maintain an effective change control system in accordance with cGMP and QS requirements. 
	7.2	 	☒	 	☐	 	Change
    Control - Inform Biofrontera prior to implementing any changes that may impact US product specifications or will affect the quality
    of finished device or drug product.


 


	8.	Purchasing
  and Material Control System




 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	8.1.
    	 	☒	 	☒	 	Establish
    and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements
    including supplier qualification and requalification activities. 
	8.2.
    	 	☒	 	☒	 	Utilize
    components and materials from appropriately approved vendors.
	8.3.
    	 	☒	 	☐	 	Pharma
    will store all materials (components, packaging materials, bulk Product, in-process Product and finished Product) in conditions appropriate
    to maintain material integrity.
	8.4.
    	 	☐	 	☒	 	Biofrontera
    will store all materials (finished product and shipping materials) in conditions appropriate to maintain material integrity.
	8.5.
    	 	☐	 	☒	 	Biofrontera
    will select and approve shipping material for the distribution of products in the US appropriate to maintain material integrity.
	8.6.
    	 	☒	 	☐	 	Label
    and Labeling- Ensure the content and format of Product labels and labeling comply with all applicable regulatory agency requirements.
	8.6.1.
    	 	☒	 	☐	 	Prepare
    and approve master label artwork according to the approved regulatory label. 
	8.6.2.
    	 	☒	 	☐	 	Maintain
    label/labeling control documents for all printed packaging components.
	8.6.3.
    	 	☒	 	☐	 	Inspect
    printed copy against a master label in accordance with standard receiving and inspection procedures.
	8.6.4.
    	 	☒	 	☐	 	Store
    labels/labeling in a limited access area and control throughout manufacturing/packaging/labeling to prevent mix-ups.
	8.6.5.
    	 	☒	 	☐	 	Reconcile
    labeling in accordance with established controls. 
	8.6.6.
    	 	☒	 	☐	 	Segregate
    and quarantine obsolete printed components. Properly destroy excess or obsolete material. 






 




    	Confidential



    	Page 8 of 14



    

 





	 	 	Pharma	 	Biofrontera	 	Responsibility
	8.6.7.
    	 	☐	 	☒	 	Ensure
    advertising and promotional materials comply with all applicable regulatory agency requirements via legal, regulatory, compliance
    and quality review.
	8.6.8.
    	 	☒		☐	 	Provide
    current copy of approved label and Prescribing Information to Biofrontera and inform Biofrontera prior to implementing any changes
    to the approved label
	8.6.9.
    	 	☐	 	☒	 	Inform
    Pharma about any new advertising material and provide copies of advertising and promotional material for submission to the Office
    of Prescription Drug Promotion (OPDP) according with the requirements described in 21 CFR 314.81(b)(3)(i) . Also, support Pharma
    as necessary for the preparation of the submission and annotation of the advertising and promotional material.
	8.6.10.
    	 	☒	 	☐	 	Submit
    advertising and promotional material to FDA.
	8.6.11.
    	 	☐	 	☒	 	Ensure
    no advertising and promotional material is distributed prior submission to the FDA.





 


	9.	Laboratory
    Testing and Quality Controls System


 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	9.1.
    	 	☒	 	☐	 	Drug
    Product: Identification, sampling, testing and disposition of raw materials shall be performed according to written specifications
    and procedures. Raw materials must be deemed acceptable in accordance with pre-established standards prior to use.
	9.2.
    	 	☒	 	☐	 	Drug
    Product Stability: Determine the minimum number of samples required for full stability testing through expiration date and perform
    stability testing according to approved stability protocol.
	9.3.
    	 	☒	 	☐	 	Drug
    Product: Review, approve and maintain current stability specifications, stability study protocols and stability data
	9.4.
    	 	☒	 	☐	 	Drug
    Product: Assign product expiration dating. 
	9.5.
    	 	☒	 	☐	 	Retain:
                                            Finished Drug Product samples shall be retained for every packaged lot for at least one (1)
                                            year beyond the expiry date of the Product. The quantity retained shall be at least twice
                                            the quantity necessary to perform full testing.

    Visually
    examine retained samples of Drug Product for evidence of deterioration at least annually. Any evidence of deterioration must be documented
    and appropriately investigated.

	9.6.
    	 	☒	 	☐	 	Provide
    paper documents required to determine acceptance of product during inspection, e.g. Certificate of Analysis (CoA)
	9.7.
    	 	☒	 	☐	 	Conduct
    finished goods inspection on the Product prior to release for distribution to Biofrontera. Ensure the finished Product meets the
    established specifications and regulatory requirements.
	9.8.
    	 	☐	 	☒	 	Conduct
    review of CoA and transport documentation prior to release for distribution to customer. Ensure the finished Product meets the established
    specifications and regulatory requirements.
	9.9.
    	 	☒	 	☒	 	All
    testing and inspection must be documented and records retained for a minimum of one (1) year beyond the expiration of the Product.


 




    	Confidential



    	Page 9 of 14



    

 


	10.	Facility
    and Equipment Controls


 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	10.1.
    	 	☒	 	☐	 	Manage
    and maintain facilities, work flow and material handling such that components, packaging materials and Product are protected from
    damage, contamination or mix-up during production or storage as long as the product is outside the USA.
	10.2.
    	 	☐	 	☒	 	Manage
    and maintain facilities, work flow and material handling such that Product is protected from damage, contamination or mix-up during
    storage after import in the USA.
	10.3.
    	 	☒	 	☐	 	Ensure
    manufacturing/packaging equipment is appropriately qualified through established validation procedures.
	10.4.
    	 	☒	 	☐	 	Maintain
    a written, validated cleaning/sanitization program to verify all equipment that substantially contacts Product is controlled for
    contamination.
	10.5.
    	 	☒	 	☐	 	Maintain
    and calibrate all equipment and instruments used to produce or test the Product or components thereof at suitable intervals in accordance
    with an established written program. All equipment shall be deemed within calibration at time of use.
	10.6.
    	 	☒	 	☐	 	Ensure
    HVAC systems are adequately qualified.


 


	11.	Production
    and Process Controls


 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	11.1.
    	 	☒	 	☐	 	Adopt
    the necessary procedures and/or controls during all phases of manufacturing/packaging to control the quality of the Product and maintain
    sufficient records to comply with regulatory requirements. 
	11.2.
    	 	☒	 	☐	 	Approve
    and document production processes, instructions, and methods that define and control the manner of production. 
	11.3.
    	 	☒	 	☐	 	Monitor
    and control process parameters and device characteristics during production by performing in-process quality control checks in accordance
    with batch record instructions. 
	11.4.
    	 	☒	 	☐	 	Evaluate
    changes to batch records against pre-established requirements.
	11.5.
    	 	☒	 	☐	 	Ensure
    appropriate manufacturing process validation and packaging qualification are performed.


 


	12.	Control
    of Non-Conforming Product, Disposition and Rework


 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	12.1.
    	 	☒	 	☒	 	Supplier
    corrective action request (SCAR) - Where a product is identified by Biofrontera as nonconforming, the product shall be returned to
    Pharma for investigation and analysis. Pharma shall cooperate with Biofrontera in working toward closure of the Biofrontera Corrective
    Action Request associated with the Product(s). 
	12.2.
    	 	☒	 	☒	 	Establish
    and maintain procedure for disposition of nonconforming product. The disposition of nonconforming product shall be documented. 
	12.3.
    	 	☒	 	☒	 	Determine
    the procedures for rework, retest, and re-evaluation of Nonconforming product to ensure product meets the specifications. Pharma
    shall document rework activities in the Batch record or equivalent and submit rework report to Biofrontera, upon request. 


 




    	Confidential



    	Page 10 of 14



    

 


	13.	Corrective
    and Preventive Action


 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	13.1.
    	 	☒	 	☒	 	Establish
    and maintain procedures for implementing a CAPA system in compliance with the cGMP requirements.
	13.2.
    	 	☒	 	☐	 	Conduct
    appropriate quality investigations upon discovery of non-conformances. Take applicable corrective actions in a manner that will be
    considered timely and effective.
	13.3.
    	 	☐	 	☒	 	Support
    quality investigations, as appropriate.
	13.4.
    	 	☒	 	☐	 	Notify
    Biofrontera in writing within two (2) working days after learning of any actual or potential problems relating to the performance
    of any product manufactured that do not meet specifications. 
	13.5.
    	 	☐	 	☒	 	Notify
    Pharma in writing within two (2) working days after learning of any actual or potential problems relating to the performance of any
    product manufactured that do not meet specifications. 


 


	14.	Handling,
  Storage, Distribution, Installation and Servicing




 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	14.1.
    	 	☒	 	☒	 	Handling:
    Establish system in place to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects do not occur during
    handling of the product(s).
	14.2.
    	 	☒	 	☒	 	Storage:
    Control storage area to prevent mix-ups, damage, deterioration, contamination, or other adverse effects pending shipment of the product(s).
	14.3.
    	 	☒	 	☒	 	Distribution:
    Establish system in place to control distribution of product(s) so that only product(s) approved for release are distributed. Ensure
    that no obsolete, rejected, expired or deteriorated products are distributed. Maintain distribution record which includes at least
    – the name and address of initial consignee; the identification and quantity of units shipped; the date shipped and any control
    number used.
	14.4.
    	 	☐	 	☒	 	Biofrontera
    will distribute all materials in US (finished product) in conditions appropriate to maintain material integrity.
	14.5.
    	 	☒	 	☐	 	Provide
    adequate installation instructions for the device.
	14.6.
    	 	☐	 	☒	 	Perform
    installation of the device in accordance with the manufacturer’s instructions.
	14.7.
    	 	☒	 	☐	 	Provide
    instructions and procedures for performing servicing and maintenance for the device.
	14.8.
    	 	☐	 	☒	 	Perform
    servicing and maintenance for the device in the USA.


 


	15.	Shipment




 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	15.1.
    	 	☐	 	☒	 	Selection
    and qualification a shipping company.
	15.2.
    	 	☒	 	☐	 	Selection
    and qualification of transport packaging for the medical device.
	15.3.
    	 	☐	 	☒	 	Selection
    and qualification of transport packaging for the drug.
	15.4.
    	 	☐	 	☒	 	Selection,
    qualification and survey of the transport process.


 




    	Confidential



    	Page 11 of 14



    

 


	16.	Records




 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	16.1.
    	 	☒	 	☐	 	Maintain
    records of each lot for a period of 1 year after the expiration date of the product. 
	16.2.
    	 	☒	 	☐	 	Records
    related to the product covered under the agreement shall be made available upon request by Biofrontera either by electronic media
    or mail. 
	16.3.
    	 	☐	 	☒	 	Maintain
    records related to drug sample distribution, customer qualification and sunshine act.


 


	17.	Complaints
  and Pharmacovigilance




 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	17.1.
    	 	☒	 	☒	 	Maintain
    a Safety Data Exchange Agreement describing the responsibilities related to Pharmacovigilance and Complaint handling in detail
	17.2.
    	 	☐	 	☒	 	Becoming
    aware of product complaints, Biofrontera shall notify Pharma within 24 hours by email or by telephone with written follow up within
    5 business days to perform quality investigation, as appropriate.
	17.3.
    	 	☒	 	☒	 	Maintain
    a written record of all customer complaints that relate to the product whether received orally or in writing. 
	17.4.
    	 	☒	 	☐	 	Prepare
    and submit any MDR and/or ADE as applicable
	17.5.
    	 	☒	 	☐	 	Sole
    authority to correspond with agency with respect to the product complaints. 
	17.6.
    	 	☒	 	☐	 	Establish
    and maintain procedure for Adverse Drug Event and Medical Device Reporting, including PADER required reporting.
	17.7.
    	 	☒	 	☐	 	Responsible
    for complying with all regulatory agency requirements pertaining to the reporting of adverse events and Medical Device Reporting
    (MDR) requirements. 
	17.8.
    	 	☒	 	☒	 	Maintain
    documentation regarding complaints and related for at least one (1) year after expiration date of the Product.


 


18.
Annual Product Reviews and Annual Reports


 


	 	 	Pharma	 	Biofrontera	 	Responsibility
	18.1.
    	 	☒	 	☐	 	APR:
    Perform and maintain written record on an annual basis, evaluating the quality standard of the drug product. 
	18.2.
    	 	☐	 	☒	 	Provide
    data/documentation required for Annual Report within thirty (30) days prior to the anniversary date to Pharma. 


 




    	Confidential



    	Page 12 of 14



    

 


19.
Company Contacts


 


	 	 	Biofrontera
    Pharma GmbH	 	Biofrontera
    Inc.
	Contract
                                            Terms /

    General
    Notices
	 	Hermann
                                            Lübbert

    CEO

    Biofrontera
    Pharma GmbH

    Hemmelrather
    Weg 201

    51377
    Leverkusen

    Germany

    Phone:
    +49 214 8763210

    Fax:
    +49 214 8763290

    email:
    h.luebbert@biofrontera.com
	 	Monica
                                            Tamborini

    COO

    Biofrontera
    Inc.

    201
    Edgewater Drive

    Wakefield,
    MA 01880

    United
    States

    Email:
    m.tamborini@biofrontera.com

    Office:
    781.245.1325

    Fax:
    781.245.1328

    e-mail:
    m.tamborini@biofrontera.com

	 	 	 	 	 
	Quality	 	Wiebke
                                            Meyer-Wendt

    Director
    Quality Management

    Biofrontera
    Pharma GmbH

    Hemmelrather
    Weg 201

    51377
    Leverkusen

    Germany

    Phone:
    +49 214 8763247

    Fax:
    +49 214 8763290

    email:
    w.wendt@biofrontera.com
	 	Darrell
                                            T. Lowman

    Quality
    Assurance Director

    Biofrontera,
    Inc.

    201
    Edgewater Drive

    Wakefield,
    MA 01880

    United
    States

    Phone:
    (781) 245-1325 Ext. 211

    Fax:
    781.245.1328

    e-mail:
    d.lowman@biofrontera.com

	 	 	 	 	 
	Production/
    Logistic	 	Montserrat
                                            Foguet

    Vice
    President Head of Regulatory Affairs and Production

    Biofrontera
    Pharma GmbH

    Hemmelrather
    Weg 201

    51377
    Leverkusen

    Germany

    Phone:
    +49 214 8763231

    Fax:
    +49 214 8763290

    email:
    m.foguet@biofrontera.com
	 	N/A


 




    	Confidential



    	Page 13 of 14



    

 


Attachment
I – Product(s)


 


	Product	 	Regulatory
    Status
	 	 	 
	Ameluz®	 	NDA
	 	 	 
	BF-RhodoLED	 	PMA
    (through NDA)


 




    	Confidential



    	Page 14 of 14



    

 


Attachment
II – Controlled documents to be provided to each other


 


	Document
    Number and Version	 	Topic	 	Owner
	SPE-QC-044,
    version 01	 	Specification
    Ameluz®	 	Pharma
	SPE-QC-036,
    version 02	 	Specification
    BF-RhodoLED	 	Pharma
	Service
    Manual BF-RhodoLED (Version 1.1-US 19.09.2016)	 	Service
    Manual BF-RhodoLED	 	Pharma
	SOP-006
    Service, Rev 001	 	SOP
    Service	 	Biofrontera
	FORM-SOP-006
    Installation Record, Rev 001	 	Installation
    BF-RhodoLED	 	Biofrontera
	SOP-012
    Complaint Program, Rev 001	 	SOP
    Complaint Program	 	Biofrontera
	FORM-SOP-012
    Complaint Form, Rev 001	 	Complaint
    Form	 	Biofrontera


 






    	Confidential