Document:

Exhibit 4. 23 

 

THIS WARRANT AND THE SECURITIES TO BE
ISSUED UPON ITS EXERCISE HAVE NOT BEEN REGISTERED UNDER THE U.S. SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), AND
THE WARRANT MAY NOT BE EXERCISED BY OR ON BEHALF OF ANY U.S. PERSON UNLESS IT IS REGISTERED UNDER THE ACT OR AN EXEMPTION FROM
SUCH REGISTRATION IS AVAILABLE. THE WARRANT MAY NOT BE EXERCISED WITHIN THE UNITED STATES AND THE SECURITIES MAY NOT BE DELIVERED
WITHIN THE UNITED STATES UPON EXERCISE UNLESS REGISTERED UNDER THE ACT OR AN EXEMPTION FROM SUCH REGISTRATION IS AVAILABLE. FOR
A PERIOD OF AT LEAST SIX MONTHS FROM THE DATE OF THIS WARRANT, IT MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES OR TO U.S. PERSONS
(OTHER THAN DISTRIBUTORS) UNLESS THE SECURITIES ARE REGISTERED UNDER THE ACT, OR ANY EXEMPTION FROM THE REGISTRATION REQUIREMENTS
OF THE ACT IS AVAILABLE. IN ADDITION, HEDGING TRANSACTIONS INVOLVING SHARES OF THE ISSUER MAY NOT BE CONDUCTED UNLESS IN COMPLIANCE
WITH THE ACT.

 

COMMON STOCK PURCHASE
WARRANT 

 

DENALI
CONCRETE MANAGEMENT, INC.

(A NEVADA CORPORATION)

 

	CERTIFICATE NUMBER:   ___________	1,267,316  WARRANTS

 

This certifies that
for value received, CANFITE BIOPHARMA LTD. or registered assigns (the “Registered Owner”), is the owner of
one million two hundred and seventy-six thousand, three hundred and sixteen (1,267,316) common stock purchase warrants (the “Warrants”),
each of which Warrants entitles the Registered Owner to purchase at any time from such time as the share capital of Denali Concrete
Management, Inc., a Nevada corporation (the “Company”) is increased to not less than 100,000,000 registered
shares and until 5:00 P.M. EST Time on November 20, 2016, (the “Exercise Period”) one fully paid and non-assessable
share of common stock, par value $0.001 per share (the “Common Stock”), of the Company, upon payment of one
United States Dollar and seventy-two cents ($1. 72) per share (the “Exercise Price”); provided, however, that
the number of shares of the Common Stock purchasable upon exercise of each Warrant may be increased or reduced and the Exercise
Price adjusted in the event of certain contingencies described below.

 

By acceptance of this
Warrant Certificate, the Registered Owner agrees to the following terms and conditions:

 

1.            Method
of Exercise.

 

(a)          This
Warrant may be exercised by delivery of this Warrant Certificate and the duly completed and executed form of election to purchase
attached hereto setting forth the number of Warrants to be exercised, together with either:

 

i.          A
certified check or bank check payable to the order of, or bank wire transfer to, the Company in the amount of the full Exercise
Price of the Common Stock being purchased;

 

ii.         Shares
of Common Stock of the Company already owned by the Registered Owner equal to the exercise price with the Common Stock valued at
its fair market value based on the closing bid quotation for such stock on the close of business on the trading day last preceding
the date of the exercise of this Warrant, as reported by the OTC Bulletin Board, or if not reported by the OTC Bulletin Board,
then as determined by the Company through any other reliable means of determination available on the close of business on the trading
day last preceding the date of such exercise;

 

    	 

    	 

    

 

 

iii.         Warrants
or other rights to purchase Common Stock valued at the amount by which the closing bid quotations (as determined in accordance
with subsection l(a)(ii) above) of the Common Stock subject to warrants or other rights exceeds the exercise or purchase price
provided on such warrants or rights; or

 

iv.         Cancellation
of debt owed by the Company to the Registered Owner, including debt incurred for professional services rendered, employment relationships,
or otherwise, upon presentation of an invoice for services provided to the Company.

 

(b)          Upon
receipt of this Warrant Certificate with the exercise form duly executed, together with payment in full of the aggregate Exercise
Price of the shares of Common Stock to be purchased, the Company shall make deliver of certificates evidencing the total number
of shares of Common Stock issuable upon such exercise, in such names and denominations as are required for delivery to, or in accordance
with the instructions of the Registered Owner. Such Common Stock certificates shall be deemed to be issued, and the person to whom
such shares of Common Stock are issued of record shall be deemed to have become a holder of record of such shares of Common Stock,
as of the date of the surrender of such Warrant Certificate and payment of the Exercise Price, whichever shall last occur; provided,
that if the books of the Company with respect to the transfer of Common Stock are then closed, such shares shall be deemed to be
issued, and the person to whom such shares of Common Stock are issued of record shall be deemed to have become a record holder
of such shares, as of the date on which such transfer books of the company shall next be open (whether before, on, or after the
expiration of the applicable Warrant Exercise Period). If this Warrant Certificate shall be surrendered for exercise within any
period during which the transfer books for the Company’s common stock or other securities purchasable upon the exercise of Warrants
are closed for any reason, the Company shall not be required to make deliver of certificates for the securities purchasable upon
such exercise until the date of the reopening of said transfer books.

 

(c)          Subject
to subsection 1(b), if less than all the Warrants evidenced by this Warrant Certificate are exercised upon a single occasion,
a new Warrant Certificate for the balance of the Warrants not so exercised shall be issued and delivered to, or in accordance with
transfer instructions properly given by, the Registered Owner, until the expiration of the applicable Warrant Exercise Period.

 

(d)          All
Warrant Certificates surrendered upon exercise of Warrants shall be canceled.

 

2.            Expiration
of Warrant. Upon the expiration of the Warrant Exercise Period, each Warrant will, respectively, expire and become void and
of no value.

 

3.            Taxes.  The
Registered Owner shall pay all documentary, stamp or similar taxes and other government charges that may be imposed with
respect to the issuance or transfer of the Warrants, or the issuance, transfer or delivery of any shares of Common Stock upon
the exercise of the Warrants.

 

4.            Mutilated
or Missing Warrant Certificates. If this Warrant Certificate is mutilated, lost, stolen, or destroyed, the Company may, on
such terms as to indemnity or otherwise as it may in its discretion impose (which shall, in the case of a mutilated Warrant Certificate,
include the surrender thereof), and upon receipt of evidence satisfactory to the Company of such mutilation, loss, theft, or destruction,
issue a substitute Warrant Certificate. Applicants for substitute Warrant Certificates shall comply with any reasonable regulations
(and pay any reasonable charges) prescribed by the Company.

 

 

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5.            Reservation
of Shares. For the purpose of enabling the Company to satisfy its obligation to issue Common Stock upon the exercise the Warrants
represented by this Warrant Certificate, the Company shall at all times reserve and keep available, free from preemptive rights,
out of the aggregate of its authorized but unissued Common Stock, the full number of shares which may be issued upon the exercise
of these Warrants; such shares of Common Stock shall upon issuance be fully paid, nonassessable, and free from all taxes, liens,
charges, and security interests with respect to the issuance thereof.

 

6.            Adjustments.
If, prior to the exercise of these Warrants, the Company shall have effected one or more stock split-ups, stock dividends or other
increases or reductions of the number of shares of its Common Stock outstanding without receiving reasonable compensation therefor
in money, services, or property, the number of shares of Common Stock subject to the Warrants shall, (i) if a net increase shall
have been effected in the number of outstanding shares of Common Stock, be proportionately increased, and the cash consideration
payable per share shall be proportionately reduced, and, (ii) if a net reduction shall have been effected in the number of outstanding
shares of Common Stock, be proportionately reduced and the cash consideration payable per share be proportionately increased.

 

7.            Notice
to Registered Owners.

 

(a)          Upon
any adjustment as described in Section 6 hereof, the Company shall, within twenty (20) days thereafter, cause written notice setting
forth the details of such adjustment, the method of calculation, and the facts upon which such calculation is based, to be given
to the Registered Owner as of the record date applicable thereto.

 

(b)          If
the Company proposes to enter into any reorganization, reclassification, sale of all or substantially all of its assets, consolidation,
merger, dissolution, liquidation, or winding up, the Company shall give notice of such fact at least twenty (20) days prior to
such action to the Registered Owner, which notice shall set forth such facts and indicate the effect of such action (to the extent
such effect may be known at the date of such notice) on the Exercise Price and the kind and amount of the shares or other securities
and property deliverable upon exercise of the Warrants. Failure of the Company to give notice shall not invalidate any corporate
action taken by the Company.

 

8.            No
Fractional Warrants or Shares. The Company shall not be required to issue fractions of Warrants upon the reissue of
Warrants, any adjustments as described in Section 6 hereof, or otherwise; but the Company in lieu of issuing any such
fractional interest, shall round up or down to the nearest full Warrant. If the total Warrants surrendered for exercise would
result in the issuance of a fractional share of Common Stock, the Company shall not be required to issue a fractional share
but rather the aggregate number of shares issuable shall be rounded up or down to the nearest full share.

 

9.            Rights
of Registered Owner. The Registered Owner, as such, shall not have any rights of a shareholder of the company, either at law
or equity, and the rights of the Registered Owner, as such, are limited to those rights expressly provided in this Warrant Certificate.
The Company may treat the Registered Owner in respect of any Warrant Certificate as the absolute owner thereof for all purposes
notwithstanding any notice to the contrary. 

 

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10.          Transfer
and Assignment. Subject to the terms hereof, this Warrant Certificate shall be freely transferable and assignable, in
whole or in part, by the Registered Owner. Any permitted transfer or assignment shall be effected by the Registered Owner (i)
completing and executing the form of assignment at the end hereof and (ii) surrendering this Warrant Certificate with such
duly completed and executed assignment form for cancellation, accompanied by funds sufficient to pay any transfer tax, at the
principal executive office of the Company; whereupon the Company shall issue, in the name or names specified by the Holder
(including the Holder) a new Warrant Certificate or Certificates of like tenor with appropriate legends restricting transfer
under the Securities Act of 1933, as amended (the “Act”) and representing in the aggregate rights to purchase the
same number of Shares as are purchasable hereunder. Prior to due presentment for transfer or assignment hereof, the Company
may treat the Registered Owner as the absolute owner hereof and of each Warrant represented hereby (notwithstanding any
notations of ownership or writing hereon made by anyone other than a duly authorized officer of the Company) for all purposes
and shall not be affected by any notice to the contrary.

 

11.           Exchange
of Warrant Certificate. This Warrant Certificate, when surrendered at the principal executive office of the Company by the Registered
Owner in person or by attorney duly authorized in writing, may be exchanged for any other Warrant Certificate of different
denominations, of like tenor and representing in the aggregate the right to purchase a like number of shares.

 

12.          
Compliance with Securities Laws. This Warrant may not be exercised or sold, transferred, assigned, or otherwise disposed
of at any time by the Registered Owner unless the transaction is registered under the Act. or, in the opinion of the Company (which
may in its discretion require the Registered Owner to furnish it
with an opinion of counsel in form and substance satisfactory to it), such exercise, sale, transfer, assignment, or other
disposition does not require registration under the
Act and a valid exemption is available under applicable federal and state securities laws.

 

IN WITNESS WHEREOF, the Company has caused
this Warrant Certificate to·be duly executed by its officer thereunto duly authorized affective the 21 day of November,
2011.

 

	 	DENALI  CONCRETE
    MANAGEMENT INC.
	 	 
	 	 	By	/s/ Mathew G. Rule
	 	 	 	Mathew G. Rule, President

 

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EXERCISE FORM

 

The undersigned
Registered Owner hereby irrevocably elects to exercise ______ Warrants represented by this Warrant Certificate, and to
purchase the shares of Common Stock of the Company issuable upon the exercise of such Warrants, and requests that
certificates for such shares shall be issued in the name of:

 

	 	 
	 	 
		 
	 	 

 

(Please print or type name and address)

 

and be delivered to:

 

	 	 
	 	 
		 
	 	 

(Please print or type name and address)

 

Please insert social security or other identifying
number: ____________________________

 

And, if such
number of Warrants shall not be all of the Warrants evidenced by the Warrant Certificate, that a new Warrant Certificate for the
balance of such Warrants be registered in the name of and delivered to, the Registered Owner at the address stated below.

 

IMPORTANT: The name of the person exercising
this Warrant must correspond with the name of the Registered Owner written on the face of this Warrant Certificate in every particular,
without alteration or any change whatever, unless it has been assigned by completing the Assignment form below.

 

	Dated: ___________ , 201 ____	 
	 	Signature of Registered Owner
	 	 
	 	 
	 	 
	 	(Please Print Address)

 

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ASSIGNMENT FORM

 

FOR VALUE RECEIVED, the undersigned hereby sells, assigns and
transfers unto:

 

	 	 
	 	 
	 	 
		 

 

(Please print or type name and address)

 

Please insert social security or other identifying number: ______________________

 

_______________ of the Warrants represented
by this Warrant Certificate, and hereby irrevocably constitutes and appoints any officer of the Company or its transfer agent and
registrar as lawful Attorney to transfer this Warrant Certificate on the books of the Company, with full power of substitution
in the premises.

 

	Dated: ___________ , 201 ____	 
	 	 
	 	Signature of Registered Owner

 

    	6Exhibit 4. 24 

 

MEMORANDUM OF UNDERSTANDING

 

This Memorandum of Understanding is entered
into on January 19, 2010 between Can-Fite Bio-Pharma Ltd., a biopharmaceutical company incorporated in Israel with principal
place of business at 10 Bareket Street, Petach Tikva, Israel (hereinafter referred to as “Can-Fite”), and Morningside
Asia Venture (HK) Limited, a company incorporated in Hong Kong, whose registered office is situated at 22/F, Hang Lung Centre,
2-20 Paterson Street, Causeway Bay, Hong Kong (“Morningside”).

 

Can-Fite has been developing the following
candidates of new drugs (“New Drugs”) and some other new drugs in the pipeline:

 

(a)         CF101:
a small molecule orally administered drug showing curing effect in a number of Phase I and Phase II clinical studies in
patients with Psoriasis, Dry Eye Syndrome and Rheumatoid Arthritis. Phase II clinical studies have been completed for the
aforesaid indications and this New Drug is now ready for Phase III clinical studies.

 

(b)         CF102:
a small molecule orally administered drug earmarked for the treatment of hepatocellular carcinoma and hepatitis C viral infection
which are currently being tested in two Phase I/II clinical studies.

 

This MOU confirms the mutual understandings
of the previous discussions between the Parties with respect to the formation of a joint venture between the Parties. The Parties
have agreed as follows:

 

		1.	Proposed Joint Venture.

 

		1.1	Can-Fite and Morningside agree in principle to establish a joint venture to develop and commercialize
certain drug candidates developed by Can-Fite in Greater China (comprising the People’s Republic of China,· Hong Kong,
Macau and Taiwan, collectively the “Territories”). Morningside and Can-Fite will make such contributions to
the joint venture as more particularly specified below and thereby Morningside will get equity interest in such joint venture as
determined in accordance with Clause 1.3 below.

 

		1.2	The principal business of the joint venture will include: arrange, organize and/or conduct
                                                           clinical studies for the new drugs developed by Can-Fite with a view to eventually obtaining relevant approvals from the
                                                           State Food and Drug Administration of the PRC (“SFDA”) for any such new drugs; arrange, organize and/or
                                                           conduct any other business or activities to accomplish the commercialization of such new drugs, including the manufacturing,
                                                           sale and distribution of such new drugs in the Territories.

 

		1.3	Morningside or an affiliate designated by Morningside will incorporate a limited liability company
in Hong Kong or a tax efficient jurisdiction (the “Company”), and the Company will issue to Morningside or its
affiliate and Can-Fite such number of new shares (the “New Shares”) as follows:

 

		(a)	for the mutual contribution at formation, Can-Fite and Morningside will be issued 100,000 and 104,100 New Shares respectively, representing 49% and 51% of equity of the Company;

 

    	- 1 -

    	 

    

 

		(b)	upon achieving the clinical milestones as described below the Company will issue additional equity
to Morningside, as follows:

 

		-	upon submission to SFDA for Investigational New Drug (IND) approval for a new drug, Morningside
will be issued additional 45/900 New Shares;

		-	upon receipt of SFDA approval to initiate clinical studies in the PRC, Morningside will be issued
additional 35,700 New Shares,

		-	upon conclusion of the Phase I clinical study in the PRC, Morningside will be issued additional
47,600 New Shares,

		-	upon conclusion of the Phase II clinical study in the PRC, Morningside will be issued additional
66,700 New Shares.

 

(c)         if Morningside is the sole investor
in any further equity financing of the Company after the financing hereunder, such further equity financing will be based on the
fair market value of the Company to be determined and mutually agreed by Can-Fite and Morningside in good faith, falling such agreement,
the fair market value will be determined by the auditors of the Company or an independent professional valuer to be jointly appointed
by Can-Fite and Morningside.

 

		2.	Parties’ contributions to the joint venture.

 

		2.1	Can-Fite shall grant to the Company the full commercial right with respect to New Drug CF102 in
the Territories on an exclusive basis, Including an exclusive right and license to arrange, organize and conduct clinical studies
for, and manufacture, sell and distribute New Drug CF102 in the Territories.

 

		2.2	Morningside shall (i) make available to the Company cash in the total amount of United States Dollars
Seven Million Five Hundred Thousand Dollars (US$7,500,000), and (ii) the expertise and the necessary intellectual resources and
contacts needed to advance the development of CF102 towards conclusion of Phase II, using its network and experience as stipulated
in Section 4.1.

 

		3.	Organization Structure.

 

The Company will establish the
following organization structure:

 

		(a)	the Company shall, directly or through one or more intermediate holding companies, form a wholly
owned subsidiary in China (the “Subsidiary”) which will be engaged in conducting or arranging clinical studies
for the New Drugs;

 

		(b)	the Company shall have a board of directors initially consisting of 3 directors, one of such directors
to be appointed by Can-Fite and two by Morningside; after the issuance of additional New Shares pursuant to Clause 1.3(b),
each Party shall have the right to appoint such number of directors In proportion to its shareholding percentage in the Company,
provided however that so long as Can-Fite’s equity in the Company remains over 5%, Can-Fite shall have the right to appoint
one director of the Company;

 

    	- 2 -

    	 

    

 

		(c)	the Company shall form a drug development steering committee which will include Can-Fite designees.

 

		4.	Further covenants of the Parties.

 

		4.1	Morningside shall make use of its established network and experience in dealing with the
                                                           central and local governments, regulatory authorities, academia and industry in the PRC, including SFDA, Ministry of Health,
                                                           leading hospitals, top universities and pharmaceutical companies, and so on, to assist the Company in carrying out its
                                                           business and achieving the corporate objectives.

 

		4.2	Can-Fite shall grant to the Company the right of first offer for the full commercial right, including
an exclusive license, in the Territories with respect to New Drug CF101 and its other new drugs in the pipeline, to the extent
possible taking into consideration Can-Fite’s activities to out-license New Drug CF101 to a global partner. When the Company
exercises such right of first offer, Can-Fite will conduct good faith negotiations with the Company within a time-frame of three
months.

 

		4.3	Can-Fite shall provide the Company with all relevant scientific, development and regulatory information
and materials, and ongoing scientific and development support, in order to enable the Company to directly apply for IND with SFDA
and to carry out the clinical studies for the New Drug CF102 in the Territories. A list of such information and materials is attached
hereto as Appendix A.

 

		5.	Due Diligence.

 

Morningside will conduct a due
diligence review of the current status of the development of the New Drugs prior to Closing. Can-Fite agrees to co-operate with
Morningside to ensure that Morningside’s due diligence exercise can be conducted effectively and in a timely manner.

 

		6.	Closing.

 

The closing of the issue of New
Shares to the Parties (“sing”) is expected to occur on or before March 31, 2010, unless subsequently
agreed in writing by the Parties.

 

		7.	Use of Proceeds.

 

The Company will use its funds
raised hereunder to carry out and complete Phase II clinical studies for New Drug CF102, and other pipeline new drugs if permitted,
in the PRC in compliance with the requirements of SFDA and as working capital.

 

		8.	Results of Clinical Studies.

 

Can-Fite shall have full access
to all clinical and pre-clinical data generated by the Company for any of the New Drugs which the Company has been granted the
right to carry out or arrange clinical studies and shall be entitled to use such data, without restriction, for all purposes outside
the Territories, provided that such use of data by Can-Fite will not prejudice the operation and interest of the Company in relation
to the New Drugs in the Territories.

 

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		9.	Pre-emptive Right.

 

Before successful commercialization
of New Drug CF102 in the Territories Can-Fite shall not sell or transfer or otherwise dispose of any of its share or equity interest
in the Company to a third party without the prior written consent of Morningside.

 

Without prejudice to the foregoing,
Can-Fite shall first grant to Morningside a right of first refusal to purchase from Can-Fite the shares in the Company that Can-Fite
intends to sell, transfer or dispose of on substantially the same terms as those offered by the third party.

 

		10.	Definitive Agreements.

 

		10.1	The transactions herein contemplated shall be set forth in the following definitive agreements
(“Agreements”), each in form and substance satisfactory to the Parties in good faith:

 

		(a)	Share Subscription Agreement;

		(b)	Shareholders’ Agreement;

		(c)	Assignment of Exclusive Right Agreement with respect to New Drug CF102; and

		(d)	Other agreements as may be reasonably required by Morningside and/or Can-Fite to be introduced
for its long term operation of the Company or as are otherwise advised by the legal advisors of the Parties, such as trademark
license from Can-Fite.

 

		10.2	The rights and obligations of the Parties in relation to the Company shall be determined in accordance
with the Agreements to be entered into between Can-Fite and Morningside, as well as the Articles of Association of the Company
in force from time to time, and the other related agreements referred to in this MOU as executed by their duly authorized representatives.

 

		11.	Confidentiality.

 

Neither Party will disclose to
any third party (other than to its respective holding companies and affiliates with a need to know and to its professional advisors)
any non-public and/or confidential information that it may acquire from or about the other, including without limitation the research
and development on science and products, businesses or investments of the other Party, and the terms and conditions of this MOU,
unless the prior written consent of the other party has been obtained or unless required by law or any relevant securities exchange.

 

		12.	Miscellaneous.

 

		12.1	Each Party shall bear its own costs and expenses in connection with this MOU and the Agreements,
and the transactions contemplated thereby, Including all fees and expenses of its advisors.

 

    	- 4 -

    	 

    

 

		12.2	This MOU may be executed in any number of counterparts,
each of which shall be an original, but all of which together shall constitute one instrument.

 

		12.3	No Party may assign this MOU or its rights or obligations
hereunder to any other person without the prior written consent of the other Party.

 

		12.4	The Parties agree that as this MOU is legally binding
and only subject to the execution and delivery of the appropriate definitive agreements by the Parties, and the Company after
its incorporation (which definitive agreements shall be concluded by the Parties in good faith based on and in accordance with
the terms and conditions set forth herein).

 

		12.5	The Parties agree with each other that it (or its affiliates)
will not enter into, continue or encourage any discussions similar in scope and geographical coverage to the business arrangements
or activities contemplated herein with any third party for a period of ninety (90) days from the signing of this MOU.

 

		12.6	This MOU shall become effective on the date of its execution
by both Parties hereto and shall continue until the Agreements are signed.

 

		12.7	This MOU shall be governed by and construed In accordance
with the laws of England. The Parties agree to submit to the non-exclusive jurisdiction of the courts of England for any matters
or disputes arising or with respect to this MOU.

 

	For and on behalf of	 	For and on behalf of
	Can-Fite Bio-Pharma Ltd.	 	Morningside Asia Venture (HK) Ltd.
	 	 	 
	/s/ Pnina Fishman, Ilan Cohn	 	/s/ Raymond Tang
	By:	 	By:	 
	Name: Pnina Fishman, Ilan Cohn	 	Name:	Raymond Tang
	Title: CEO, Vice Chairman	 	Title:	Director

 

    	- 5 -

    	 

    

 

Appendix A

Required Information and materials for
IND application in PRC

 

(The list below is not intended to be exhaustive
and may be modified and/or supplemented.)

 

		1.	Chemical/Pharmaceutical data

 

		1)	Summary of Pharmaceutical Study.

		2)	Research information and relevant literature of the production process of the drug substance, research
information and relevant literature of formula and process of the preparations.

		3)	Study information and relevant literature for the chemical structure and components determination.

		4)	Study Information and literature for quality specification.

		5)	Draft of quality specification and notes, and providing reference standard.

		6)	Certificate of analysis.

		7)	The source of excipient and quality specification.

		8)	Stability study and relevant literature.

		9)	Selection basis and quality specification of immediate packing material and container.

 

		2.	Pharmacology and toxicology study information

 

		10)	Summary of pharmacology and toxicology study.

		11)	Primary pharmacodynamics study and literature.

		12)	General Pharmacology study and literature.

		13)	Acute/single dose toxicity study and literature.

		14)	Repeated dose toxicity study and literature.

		15)	Special safety study and literature of hypersensitive (topical, systemic and photo-toxicity),
hemolytic and topical irritative (blood vessel, skin, mucous membrane, and muscle) reaction related to topical and systemic use
of the drugs.

		16)	Compound formula analysis.

		17)	Study and literature of mutagencity test.

		18)	Study and literature of reproductive toxicity.

		19)	Study and literature of carcinogenicity test.

		20)	Study and literature of drug dependence test.

		21)	Animal Pharmacokinetics Study data.

 

		3.	Clinical Study Information

 

		22)	summary of global clinical study Information.

		23)	Clinical study protocol.

		24)	Investigator’s Brochure.

		25)	Draft of Informed Consent Form, approval of the Ethics Committee.

		26)	Clinical study report.

 

		4.	General Information

 

		27)	Name of the drugs, including general and chemical name, molecular structure, molecular weight and
molecular formula etc.

		28)	Certified Documents related to the manufacturer, research lab and all the correspondences with
USFDA.

		29)	Rational for development Including a summary of its competitors and latest literature.

		30)	Summary of main study work, which should include safety, efficacy and quality control.

		31)	Packaging insert, packaging and labelling.

		32)	Related patents.

 

    	- 6 -

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