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Erie Indemnity Company Management: Philip A. Garcia
Erie Insurance Group, located in Erie, Pa., is a regional insurer of personal and small commercial property and casualty insurance, operating in 11 states and the District of Columbia.
Positrons and Positronium for Polymer Thin Film Analysis (Author: A.A. Garcia)
IOS Press Nieuwe Hemweg 6B, 1013 BG Amsterdam, The Netherlands Tel.: +31 20 688 3355, Fax: +31 20 687 0039 E-mail: info@iospress.
Sustainable information ecosystems (Rune Gustavsson, Martin Fredriksson, A. Garcia, C. Lucena, F.
Rune Gustavsson; Martin Fredriksson pp. in Software engineering for large-scale multi-agent systems: Research issues and practical applications, Springer Verlag, , 2003.
http://www.bth.se/fou/forskinfo.nsf/alfs/4565564155c36e2dc1256dc500369c59
A. Garcia's Friends - Website Magazine
Copyright © 2008 Website Magazine All Rights Reserved - 3952 N Avondale, Chicago, IL 60641 Toll Free: 1.800.817.1518 - International: 1.773.628.2779 - Fax: 1.773.272.
http://www.websitemagazine.com/content/members/agarcia/friends/default.aspx
News from Zibb.com
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Census Bureau Reaffirms Commitment to Working With American Indians and Alaska Natives - Zibb.com
Oct 17, 2008 (BUSINESS WIRE) --
U.S. Census Bureau:
What: Census Bureau Director Steve H. Murdock will be joined by National
Congress of American Indians President Joe A. Garcia as he signs the
Census Bureau's first American Indian and Alaska Native policy. The
signing ceremony will take place before the General Assembly at
NCAI's 65th annual convention. This policy reaffirms the Census
Bureau's strong commitment to working with American Indian and
Alaska Natives through this official government-to-government
relationship. Murdock will also discuss the upcoming 2010 Census and
the work conducted throughout the decade to ensure there is an
accurate and complete count of the American Indian and Alaska Native
population.
When: Tuesday, Oct. 21, 10:45 - 11:05 a.m. (Mountain Daylight Time)
Who: Steve H. Murdock, director, U.S. Census Bureau
Joe A. Garcia, president, National Congress of American Indians
Members of the National Congress of American Indians Executive Board
Where: National Congress of American Indians General Assembly
Phoenix Convention Center
100 North Third Street
Phoenix, AZ 85004
SOURCE: U.S. Census Bureau
U.S. Census Bureau Megan Kindelan Public Information Office (301) 763-3691/(863) 289-9523 (cell) e-mail: pio@census.gov
Tags: alaska arizona census congress executive government policy population president
TSX Venture Exchange Daily Bulletins - Zibb.com
VANCOUVER, Oct. 20, 2008 (Canada NewsWire via COMTEX) --
<<
TSX VENTURE COMPANIES
BULLETIN TYPE: Notice to Issuers
BULLETIN DATE: October 20, 2008
Re: Restated Deal Structure and Founder Shares Guidelines
Background
The TSX Venture Exchange (the "Exchange"), in a bulletin published on
December 11, 2007, set out capital structure guidelines for non-CPC issuers
having issued, prior to listing, securities to principals or third parties for
nominal consideration (the "Deal Structure and Founder Shares Guidelines").
The Exchange may vary these guidelines from time to time, at the election of
the Exchange, in response to general market conditions. Founder Shares
Guidelines which are varied will be restated with amendments underlined for
issuer ease of reference. This bulletin is the first restated and amended Deal
Structure and Founder Shares Guidelines and supersedes those guidelines
published on December 11, 2007. The purpose of the amendments in these
restated and amended guidelines is to reduce the threshold of an acceptable
financing from $10 million to $5 million and to clarify further what is
considered by the Exchange to be an acceptable supporting valuation.
Amendments to Policy
Effective Date
The principles underlying the guidelines set out in this bulletin will be
contained in an amended Exchange Policy 2.1 which the Exchange expects to
issue in its next revision. The information set out in this bulletin should be
used as additional guidance by market participants in determining whether the
capital structure of an issuer will be acceptable to the Exchange. The
concepts set out in this bulletin will be applied by the Exchange to new
listing submissions (including listing submissions involving IPOs, RTOs or
QTs) effective from the date of this bulletin. Exchange staff will continue to
work with market participants to ensure their deal structures are acceptable
and encourage issuers to pre-file their submissions accordingly. The contents
of this bulletin do not otherwise affect any existing listing requirements
contained in Exchange policies.
General Concept
The Exchange will not object to certain transactions where the amount of
"Founder Shares", as defined below, equals, or falls below, a determined
threshold.
Founder Shares
Founder Shares means any security issued, or proposed to be issued, to:
(i) any person for less than $0.05 per security;
(ii) a party related to the issuer for the purchase of an asset which
cannot be acceptably valued under sections 4.2(a), (b), (c), (d),
(e), (f), (g) or (i) of Exchange Policy 5.4;
(iii) a principal to settle a debt or obligation for less than the last
price per security which the security was issued for or at a price
per security which the Exchange does not consider reasonable given
the circumstances; or
(iv) a principal for the primary purpose of increasing that principal's
interest in the issuer without a corresponding tangible benefit to
the issuer.
The Exchange will consider the number of Founder Shares in the aggregate
in determining whether a transaction structure is acceptable under this
bulletin and the amended policy. In addition, the final determination on
whether a person is or is not a principal or a party related to the issuer
will be that of the Exchange, using its discretion and based upon the
particular facts of the submission and the resulting interest of a security
holder in the issuer after giving effect to the transaction. In exercising its
discretion, the Exchange may deem certain securities, which have been or are
proposed to be issued, and which may not technically be captured under the
"Founder Shares" definition noted above, to be, nonetheless, Founder Shares.
Allowable Transactions
The Exchange will not object to:
(i) a transaction which otherwise satisfies applicable existing listing
requirements and under which the issuer has issued, or proposes to
issue, Founder Shares, which, cumulatively (and with Founder Shares
being calculated on a fully diluted basis), represent, or would
represent no more than 15% of the issuers' issued and outstanding
securities at the time of listing; or
(ii) a transaction which otherwise satisfies applicable listing
requirements and under which an issuer has issued, or proposes to
issue, Founder Shares which, cumulatively (and with Founder Shares
being calculated on a fully diluted basis), represent, or would
represent, in excess 15% of the issuer's issued and outstanding
securities at the time of listing, provided the issuer also
completes an acceptable financing concurrent with the listing.
The Exchange will consider an acceptable financing to be any equity
financing which:
(A) raises gross proceeds of no less than $5,000,000, of which no less
than 75% has been subscribed for by arm's length parties; or
(B) results in the issuance of no less than 50% of the issued and
outstanding securities of issuer at the time of listing, of which no
less than 75% has been subscribed for by arm's length parties.
Application
As noted above, guidance under this bulletin, and the provisions of the
amended policy, will apply to all new listing submissions effective today.
However, in the case of industrial, technology or research & development
issuers, the Exchange may be more flexible in its application of the Founder
Shares definition. For these issuers, the Exchange may dispense with the
requirement of an acceptable supporting valuation or otherwise apply
flexibility in its interpretation of these guidelines if the person or persons
to whom those securities have been issued has or have clearly contributed a
tangible benefit to the issuer over time. The Exchange encourages all issuers
to meet with Exchange staff prior to making a listing submission if they have
further questions regarding their capital structure.
If you have questions about these changes, please contact:
In British Columbia: Andrew Hancharyk, Phone: 604-602-6982,
Fax: 604-844-7502
In Alberta: Peter Varsanyi, Phone: 403-218-2860, Fax: 403-234-4211
In Ontario: Tim Babcock, Phone: 416-365-2202, Fax: 416-365-2224
In Québec: Sylvain Martel, Phone: 514-788-2411, Fax: 514-788-2421
TYPE DE BULLETIN : Avis aux émetteurs
DATE DU BULLETIN : Le 20 octobre 2008
Objet : Version modifiée des lignes directrices sur la structure
d'opération et les actions de fondateur
Contexte
Dans un bulletin publié le 11 décembre 2007, la Bourse de croissance TSX
(la "Bourse") présentait des lignes directrices sur la structure du capital à
l'intention des émetteurs, autres que les SCD, ayant émis avant leur
inscription des titres à des principaux intéressés ou à des tiers pour une
contrepartie symbolique. La Bourse peut modifier ces lignes directrices à son
gré pour tenir compte de la conjoncture du marché. La version modifiée des
lignes directrices sur les actions de fondateur sera publiée avec les
modifications soulignées pour en faciliter la consultation par les émetteurs.
Le présent bulletin constitue la première version modifiée des lignes
directrices sur la structure d'opération et les actions de fondateur et
remplace les lignes directrices du 11 décembre 2007. Les modifications visent
à faire passer le seuil d'un financement acceptable de 10 millions de dollars
à 5 millions de dollars, et à clarifier ce que la Bourse considère comme une
attribution de valeur acceptable.
Modification de la politique
Date d'effet
Les principes sur lesquels reposent les lignes directrices qui sont
énoncées dans le présent bulletin seront intégrés dans la Politique 2.1
modifiée que la Bourse prévoit publier au moment de la prochaine mise à jour.
L'information contenue dans le présent bulletin servira d'indications
supplémentaires aux participants du marché qui doivent déterminer si la
structure du capital d'un émetteur sera jugée acceptable par la Bourse. La
Bourse appliquera les principes dont il est question ici aux demandes de
nouvelles inscriptions (y compris celles qui sont présentées dans le cadre
d'un premier appel public à l'épargne, d'une prise de contrôle inversée ou
d'une opération admissible) présentées à partir de la date du présent
bulletin. Le personnel de la Bourse continuera de travailler avec les
participants du marché pour veiller à ce que la structure de leur opération
soit acceptable et incitera les émetteurs à déposer au préalable leur demande.
Le contenu du présent bulletin ne modifie aucune des autres exigences
d'inscription que contiennent les politiques en vigueur de la Bourse.
Principe général
La Bourse ne s'opposera pas à certaines opérations si le nombre d'"actions
de fondateur", au sens attribué à ce terme ci-après, est égal ou inférieur à
un seuil déterminé.
Actions de fondateur
Les actions de fondateur s'entendent de tout titre émis ou dont on
projette l'émission à l'une des personnes suivantes :
(i) toute personne, à un prix inférieur à 0,05 $ l'action;
(ii) une personne reliée, dans le cadre de l'achat d'un actif auquel on
ne peut attribuer une valeur de facon acceptable conformément aux
alinéas 4.2a), b), c), d), e), f), g) ou i) de la Politique 5.4 de
la Bourse;
(iii) un principal intéressé, en règlement d'une dette ou d'une
obligation, à un prix inférieur au dernier prix auquel le titre a
été émis ou à un prix que la Bourse considère comme déraisonnable
dans les circonstances;
(iv) un principal intéressé, en vue principalement d'augmenter la
participation de ce dernier dans l'émetteur, sans que l'émetteur en
tire concrètement un avantage réciproque.
La Bourse tiendra compte du nombre global d'actions de fondateur pour
déterminer si la structure d'une opération est acceptable aux termes du
présent bulletin et de la politique modifiée. De plus, la Bourse décidera en
définitive si une personne est ou non un principal intéressé ou une personne
reliée, en usant de son pouvoir discrétionnaire et en se fondant sur les faits
de la demande et sur la participation que la personne aura dans l'émetteur
après l'opération. Dans l'exercice de son pouvoir discrétionnaire, la Bourse
pourra néanmoins considérer comme des actions de fondateur certains titres
émis ou dont on projette l'émission qui ne sont pas en principe compris dans
la définition d'"actions de fondateur" donnée ci-dessus.
Opérations permises
La Bourse ne s'opposera pas aux opérations suivantes :
(i) l'opération qui répond par ailleurs aux exigences d'inscription en
vigueur applicables et dans le cadre de laquelle l'émetteur a émis
ou projette d'émettre des actions de fondateur qui représentent ou
représenteraient dans l'ensemble (le nombre d'actions de fondateur
étant calculé après dilution) au plus 15 % de ses titres émis et en
circulation au moment de l'inscription;
(ii) l'opération qui répond par ailleurs aux exigences d'inscription
applicables et dans le cadre de laquelle l'émetteur a émis ou
projette d'émettre des actions de fondateur qui représentent ou
représenteraient dans l'ensemble (le nombre d'actions de fondateur
étant calculé après dilution) plus de 15 % de ses titres émis et en
circulation au moment de l'inscription, à condition que l'émetteur
réalise également un financement acceptable simultanément à
l'inscription.
La Bourse considérera comme acceptable tout financement par actions qui
répond à l'un des critères suivants :
A) le produit brut réuni s'élève à au moins 5 000 000 $, et 75 % au
moins des titres émis ont été souscrits par des personnes sans lien
de dépendance;
B) le nombre de titre émis équivaut à 50 % au moins des titres émis et
en circulation de l'émetteur au moment de l'inscription, et 75 % au
moins des titres émis ont été souscrits par des personnes sans lien
de dépendance.
Application
Les indications données dans le présent bulletin et les dispositions de la
politique modifiée s'appliqueront à toutes les demandes de nouvelles
inscriptions présentées à partir de la date du présent bulletin. Cependant, en
ce qui concerne les émetteurs des secteurs de l'industrie, de la technologie
et de la recherche et du développement, la Bourse pourrait se montrer plus
souple dans l'application de la définition des actions de fondateur. Elle
pourrait dispenser ces émetteurs de l'obligation de fournir une attribution de
valeur acceptable ou par ailleurs assouplir son interprétation des lignes
directrices si la ou les personnes à qui les titres ont été émis ont
clairement apporté un avantage concret à l'émetteur au fil du temps. La Bourse
demande à tous les émetteurs qui ont d'autres questions au sujet de leur
structure du capital de rencontrer son personnel avant de déposer une demande
d'inscription.
Si vous avez des questions au sujet de ces modifications, veuillez
communiquer avec l'une des personnes suivantes :
En Colombie-Britannique : Andrew Hancharyk, tél. : 604-602-698,
téléc. : 604-844-7502;
En Alberta : Peter Varsanyi, tél. : 403-218-2860, téléc. : 403-234-4211;
En Ontario : Tim Babcock, tél. : 416-365-2202, téléc. : 416-365-2224;
Au Québec : Sylvain Martel, tél. : 514-788-2411, téléc. : 514-788-2421.
TSX-X
--------------------------------
AMADOR GOLD CORP. ("AGX")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation with respect to
the first tranche of a Non-Brokered Private Placement announced September 9,
2008 and October 7, 2008:
Number of Shares: 13,357,500 flow-through shares
2,063,050 non flow-through
Purchase Price: $0.10 per share
Warrants: 15,420,050 share purchase warrants to purchase
15,420,050 shares
Warrant Exercise Price: $0.15 for a two year period
Number of Placees: 15 placees
Finders' Fees: Research Capital Corp. - $14,456.00
Limited Market Dealership - $80,000
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company
must issue a news release announcing the closing of the private placement and
setting out the expiry dates of the hold period(s). The Company must also
issue a news release if the private placement does not close promptly.
TSX-X
--------------------------------
ANIMAS RESOURCES LTD. ("ANI")
BULLETIN TYPE: Property-Asset or Share Purchase Agreement
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation in connection
with an Option Agreement dated October 15, 2008 between the Company and
Mineral Lixivian, S.A. de C.V. (Mayo Ramirez Guitiérrez, Efrén Rosas Briones
and Samuel Ocan*a Garcia) with respect to the Ophelia and Santa Gertrudis
concessions located in the Santa Teresa mining district, Mexico. The aggregate
consideration is US$422,000 over an 18 month period and 217,000 common shares.
TSX-X
--------------------------------
ARCHANGEL DIAMOND CORPORATION ("AAD")
BULLETIN TYPE: Halt
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
Effective at the open, October 20, 2008, trading in the shares of the
Company was halted pending an announcement; this regulatory halt is imposed by
Investment Industry Regulatory Organization of Canada, the Market Regulator of
the Exchange pursuant to the provisions of Section 10.9(1) of the Universal
Market Integrity Rules.
TSX-X
--------------------------------
ARCHANGEL DIAMOND CORPORATION ("AAD")
BULLETIN TYPE: Resume Trading
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
Effective at 7:15 a.m. PST, October 20, 2008, shares of the Company
resumed trading, an announcement having been made over Canada News Wire.
TSX-X
--------------------------------
ATW GOLD CORP. ("ATW")
(formerly ATW Venture Corp. ("ATW"))
BULLETIN TYPE: Name Change
BULLETIN DATE: October 20, 2008
TSX Venture Tier 1 Company
Pursuant to a resolution passed by shareholders October 7, 2008, the
Company has changed its name as follows. There is no consolidation of capital.
Effective at the opening, October 21, 2008, the common shares of ATW Gold
Corp. will commence trading on TSX Venture Exchange, and the common shares of
ATW Venture Corp. will be delisted. The Company is classified as a 'Mining'
company.
Capitalization: Unlimited shares with no par value of which
60,471,256 shares are issued and outstanding
Escrow: Nil
Transfer Agent: Computershare Trust Company
Trading Symbol: ATW (unchanged)
CUSIP Number: 002105 10 4 (new)
TSX-X
--------------------------------
AUSAM ENERGY CORPORATION ("AZE")
BULLETIN TYPE: Warrant Price Amendment
BULLETIN DATE: October 20, 2008
TSX Venture Tier 1 Company
TSX Venture Exchange has consented to the temporary reduction in the
exercise price to US$1.50 of the warrants described below. The reductions will
be in effect from October 20, 2008 to November 18, 2008 (the 'Reduction
Period'), following which any unexercised warrants will revert to their
original exercise price. During the Reduction Period only, the warrants will
be exercisable for Units instead of common shares. Each Unit will consist of
one common share and one-half of one share purchase warrant ('Incentive
Warrant'). Each whole Incentive Warrant will exercisable for one additional
common share for a period of five years from the date of issuance at a price
of US$1.50 in the first two years, US$1.65 in the third year, US$1.82 in the
fourth year, or US$2.00 in the fifth year.
Private Placement No. 1:
No. of Warrants: 3,092,682
Expiry Date of Warrants: February 8, 2012
Original Exercise Price of Warrants: $3.25
New Exercise Price of Warrants: US$1.50
*These warrants were issued pursuant to a private placement of
30,926,842 shares with 15,463,421 share purchase warrants attached, which
was accepted for filing by the Exchange effective April 10, 2007.
Private Placement No. 2:
No. of Warrants: 1,996,666
Expiry Date of Warrants: February 8, 2012
Original Exercise Price of Warrants: $3.75
New Exercise Price of Warrants: US$1.50
*These warrants were issued pursuant to a private placement of
19,966,666 First Preferred Shares, Series 2 with 9,983,333 share purchase
warrants attached, which was accepted for filing by the Exchange
effective April 10, 2007.
Private Placement No. 3:
No. of Warrants: 125,685
Expiry Date of Warrants: September 7, 2012
Original Exercise Price of Warrants: $3.25
New Exercise Price of Warrants: US$1.50
*These warrants were issued pursuant to a private placement of
1,256,852 shares with 628,425 share purchase warrants attached, which was
accepted for filing by the Exchange effective April 11, 2008.
Private Placement No. 4:
No. of Warrants: 4,461,099
Expiry Date of Warrants: July 3, 2012
Original Exercise Price of Warrants: $3.00
New Exercise Price of Warrants: US$1.50
*These warrants were issued pursuant to a private placement of a
convertible debenture in the amount of US$25,000,000 with 22,305,496
share purchase warrants attached, which was accepted for filing by the
Exchange effective July 11, 2007.
*Note that the private placement information included above reflects
the figures prior to the Company's share consolidation effective
September 27, 2007.
TSX-X
--------------------------------
BAYMOUNT INCORPORATED ("BYM")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation with respect to
a Non-Brokered Private Placement announced August 28, 2008:
Number of Shares: 3,100,000 shares
Purchase Price: $0.10 per share
Number of Placees: 3 placees
Insider/Pro Group Participation:
Insider equals Y/
Name ProGroup equals P/ No. of Shares
F. Helmut Biemann Y 400,000
For further details, please refer to the Company's news release dated
August 28, 2008.
TSX-X
--------------------------------
BTB REAL ESTATE INVESTMENT TRUST ("BTB.UN")
BULLETIN TYPE: Notice of Distribution
BULLETIN DATE: October 20, 2008
TSX Venture Tier 1 Company
The Issuer has declared the following distribution:
Distribution per Trust Unit: $0.01333
Payable Date: November 14, 2008
Record Date: October 31, 2008
Ex-Distribution Date: October 29, 2008
TSX-X
--------------------------------
GENOIL INC. ("GNO")
BULLETIN TYPE: Private Placement-Non-Brokered, Convertible Debenture/s
BULLETIN DATE: October 20, 2008
TSX Venture Tier 1 Company
TSX Venture Exchange has accepted for filing documentation with respect to
a Non-Brokered Private Placement:
Convertible Debenture: $1,227,355.84
Conversion Price: Convertible into common shares at a rate of
$0.27 of principal per share until maturity.
Maturity date: October 6, 2009
Warrants: 1,136,442
Each warrant is exercisable for one common share
at a price of $0.41 for a period of one year
from the date of issuance.
Interest rate: 12 %
Number of Placees: 4 placees
Insider/Pro Group Participation:
Insider equals Y/ Principal
Name ProGroup equals P/ Amount Warrants
Lifschultz Enterprises
Co., LLC Y $834,581.78 772,761
Sidney B. Lifschultz
1992 Family Trust Y $129,218.66 119,647
David K. Lifschultz Y $131,777.70 122,017
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company
must issue a news release announcing the closing of the private placement and
setting out the expiry dates of the hold period(s).
TSX-X
--------------------------------
GOLD STAR RESOURCES CORP. ("GXX")
BULLETIN TYPE: Warrant Term Extension
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has consented to the extension in the expiry date of
the following warrants:
No. of Warrants: 1,550,000
Original Expiry Date of Warrants: November 20, 2008
New Expiry Date of Warrants: November 20, 2009
Exercise Price of Warrants: $0.15
These warrants were issued pursuant to a private placement of 3,070,000
shares with 3,070,000 share purchase warrants attached, which was accepted for
filing by the Exchange effective November 16, 2007.
TSX-X
--------------------------------
MACDONALD MINES EXPLORATION LTD. ("BMK")
BULLETIN TYPE: Property-Asset or Share Purchase Agreement
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation relating to an
option agreement (the "Agreement") dated October 2, 2008, between Shoreham
Resources Ltd. (the "Optionor") and MacDonald Mines Exploration Ltd (the
"Company"). Pursuant to the Agreement, the Company shall have the option to
acquire an undivided 40% interest in the Sachigo Lake Property (the
"Property") (the Company will acquire an undivided 100% interest in the event
Escape Group Inc. does not earn it's 60% interest in the Property pursuant to
its pre-existing option agreement with the Optionor). The interest in the
Property shall be subject to a 2.5% net smelter return royalty, of which the
Company shall have the right to 'buy back' 1% at any time for the sum of
$1,000,000.
In order to earn its interest in the Property, the Company must pay the
Optionor an aggregate of $150,000 within three years, issue 300,000 common
shares within one year, and issue 600,000 common share purchase warrants (each
exercisable into 1 common share at a price of $0.40 for a period of two years
from issuance) within one year.
TSX-X
--------------------------------
PETROGLOBE INC. ("PGB")
BULLETIN TYPE: Property Asset or Share Disposition Agreement
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing a Letter of Intent ("LOI")
between PetroGlobe Inc. (the "Company") and 1427668 Alberta Ltd. (the
"Purchaser"). Pursuant to the LOI, the Company will sell 100% of the common
shares it holds in PetroGlobe (Canada) Ltd. to the Purchaser. In
consideration, the Company will receive $350,000.
TSX-X
--------------------------------
PITCHSTONE EXPLORATION LTD. ("PXP")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 1 Company
TSX Venture Exchange has accepted for filing documentation with respect to
a Non-Brokered Private Placement announced September 26, 2008:
Number of Shares: 2,501,000 flow through shares
Purchase Price: $0.60 per share
Number of Placees: 7 placees
Finders' Fees: $58,800 payable to Dundee Securities Corporation
$15,000 payable to Toll Cross Securities Inc.
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company
must issue a news release announcing the closing of the private placement and
setting out the expiry dates of the hold period(s). The Company must also
issue a news release if the private placement does not close promptly.
TSX-X
--------------------------------
PLATINEX INC. ("PTX")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation with respect to
a Non-Brokered Private Placement (first tranche) announced October 3, 2008:
Number of Shares: 1,583,333 flow-through shares and
2,300,000 non flow-through shares
Purchase Price: $0.15 per flow-through share
$0.125 per non flow-through share
Warrants: 2,300,000 share purchase warrants to purchase
2,300,000 shares
Warrant Exercise Price: $0.35 for a two year period
Number of Placees: 12 placees
Insider/Pro Group Participation:
Insider equals Y/
Name ProGroup equals P/ No. of Shares
James Marrelli Y 320,000
Korine Craig Y 200,000
Bruce Reilly Y 300,000
James Trusler Y 480,000
Finder's Fees: $3,000 in cash payable to BMO Nesbitt Burns
Ltee., Montreal, QC.
For further details, please refer to the Company's news release dated
October 3, 2008.
TSX-X
--------------------------------
RADISSON MINING RESOURCES INC. ("RDS")
BULLETIN TYPE: Property-Asset or Share Purchase Amending Agreement
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing the documentation relating to
an amended option agreement, dated October 1, 2008. The amendment relates to
payment terms within the original August 29, 2005 agreement, under which the
Company acquired a property located in the Dryden region of the province of
Ontario.
Under the terms of the amended agreement, the final payment, which was to
consist of 20,000 class A shares of the Company and $20,000 in cash will
instead be made with 220,000 class A shares and $5,000 in cash.
For further information, please refer to the Company's press release dated
October 17, 2008.
RESSOURCES MINIÈRES RADISSON INC. ("RDS")
TYPE DE BULLETIN : Modification à une convention d'achat de propriété,
d'actif ou d'actions
DATE DU BULLETIN : Le 20 octobre 2008
Société du groupe 2 de TSX Croissance
Bourse de croissance TSX a accepté le dépôt de documents relativement à un
amendement à une convention d'option datée du 1er octobre 2008. L'amendement
concerne les modalités de paiement aux termes de l'entente originale du 29
août 2005, selon laquelle la société a acquis une propriété situé dans la
région Dryden en Ontario.
Aux termes de l'entente amendée, le dernier paiement, qui aurait consisté
en 20 000 actions catégorie A de la société et 20 000 $ en espèces, consistera
en 220 000 actions catégorie A et 5 000 $ en espèces.
Pour plus d'information, veuillez vous référer au communiqué de presse
émis par la société le 17 octobre 2008.
TSX-X
--------------------------------
SEDEX MINING CORP. ("SDN")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation with respect to
the first tranche of a Non-Brokered Private Placement announced September 9,
2008:
Number of Shares: 6,666,667 flow through shares
625,000 non-flow through shares
Purchase Price: $0.06 per share
Warrants: 7,291,667 share purchase warrants to purchase
7,291,667 shares
Warrant Exercise Price: $0.10 for a two year period
Number of Placees: 2 placees
Finder's Fee: $32,000 payable to BMO Nesbitt Burns
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company
must issue a news release announcing the closing of the private placement and
setting out the expiry dates of the hold period(s). The Company must also
issue a news release if the private placement does not close promptly.
TSX-X
--------------------------------
SILK ROAD RESOURCES LTD. ("SIL")
BULLETIN TYPE: Private Placement-Non-Brokered, Convertible Debenture/s
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation with respect to
a Non-Brokered Private Placement announced July 3, 2008, July 16, 2008 and
August 21, 2008:
Convertible Debenture: $500,000
Conversion Price: Convertible into common shares at $1.00 of
principal outstanding
Maturity date: July 10, 2011
Interest rate: 7% per annum
Number of Placees: 1 placee
Insider/Pro Group Participation:
Insider equals Y/
Name ProGroup equals P/ Principal Amount
Patriarco Holdings Ltd. Y $500,000
(Anthony Patriarco
and Nancy Patriarco)
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company
must issue a news release announcing the closing of the private placement and
setting out the expiry dates of the hold period(s). The Company must also
issue a news release if the private placement does not close promptly.
TSX-X
--------------------------------
SOLID RESOURCES LTD. ("SRW")
BULLETIN TYPE: Shares for Debt
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing the Company's proposal to
issue 300,000 shares at a deemed price of $0.20 to settle outstanding debt for
$60,000.
Number of Creditors: 1 Creditor
Insider/Pro Group Participation:
Deemed
Insider equals Y/ Amount Price No. of
Creditor Progroup equals P Owing per Share Shares
Kevin Moore Y $60,000 $0.20 300,000
The Company shall issue a news release when the shares are issued and the
debt extinguished.
TSX-X
--------------------------------
SOLID RESOURCES LTD. ("SRW")
BULLETIN TYPE: Shares for Debt
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing the Company's proposal to
issue 551,680 shares at a deemed price of $0.20 to settle outstanding debt for
$100,836.
Number of Creditors: 3 Creditors
Insider/Pro Group Participation:
Deemed
Insider equals Y/ Amount Price No. of
Creditor Progroup equals P Owing per Share Shares
McKinders
Financial (Harry
McKinders) Y $74,802 $0.20 424,010
Leonard Trump Y $15,534 $0.20 77,670
The Company shall issue a news release when the shares are issued and the
debt extinguished.
TSX-X
--------------------------------
TEARLACH RESOURCES LIMITED ("TEA")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for expedited filing documentation with
respect to a Non-Brokered Private Placement announced October 15, 2008:
Number of Shares: 1,000,000 shares
Purchase Price: $0.05 per share
Warrants: 1,000,000 share purchase warrants to purchase
1,000,000 shares
Warrant Exercise Price: $0.10 for a two year period
Number of Placees: 2 placees
Insider/Pro Group Participation:
Insider equals Y/
Name ProGroup equals P/ No. of Shares
Richard Pomper P 500,000
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company
must issue a news release announcing the closing of the private placement and
setting out the expiry dates of the hold period(s). The Company must also
issue a news release if the private placement does not close promptly.
TSX-X
--------------------------------
VAULT MINERALS INC. ("VMI")
BULLETIN TYPE: Property-Asset or Share Purchase Agreement
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation pertaining to
an option agreement (the "Agreement") dated September 24, 2008, between Vault
Minerals Inc. (the "Company") and four arms-length parties (collectively, the
"Optionors"). Pursuant to the Agreement, the Company shall have the option to
acquire a 100% undivided interest in a mining claim (the "Property") located
in Teck Township of Ontario.
As consideration, the Company must pay the Optionors an aggregate of
$27,000, issue 90,000 common shares, and incur a minimum aggregate of $50,000
in exploration expenditures on the Property within the first two years. The
Company must pay the Optionors a 2% royalty (the "Royalty") from any
production on the Property. Furthermore, the Company has the option to
purchase 50% of the Royalty by making a further aggregate payment of
$1,000,000 to the Optionors.
For further information, please refer to the Company's press release dated
October 9, 2008.
TSX-X
--------------------------------
VAULT MINERALS INC. ("VMI")
BULLETIN TYPE: Property-Asset or Share Purchase Agreement
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation pertaining to
an option agreement (the "Agreement") dated September 24, 2008, between Vault
Minerals Inc. (the "Company") and two arms-length parties (collectively, the
"Optionors"). Pursuant to the Agreement, the Company shall have the option to
acquire a 100% undivided interest in a mining claim (the "Property") located
in Teck Township of Ontario.
As consideration, the Company must pay the Optionors an aggregate of
$8,000, issue 30,000 common shares and incur a minimum of $5,000 in
exploration expenditures on the Property within the first year. The Company
must pay the Optionors a 2% royalty (the "Royalty") from any production on the
Property. Furthermore, the Company has the option to purchase 50% of the
Royalty by making a further aggregate payment of $1,000,000 to the Optionors.
For further information, please refer to the Company's press release dated
October 9, 2008.
TSX-X
--------------------------------
VENGA AEROSPACE SYSTEMS INC. ("VAV")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation with respect to
a Non-Brokered Private Placement announced October 10, 2008:
Number of Shares: 10,900,000 shares
Purchase Price: $0.05 per share
Number of Placees: 7 placees
Insider/Pro Group Participation:
Insider equals Y/
Name ProGroup equals P/ No. of Shares
David Jacob Rotfleisch Y 2,000,000
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company has
issued a news release announcing the closing of the private placement and
setting out the expiry dates of the hold period(s).
TSX-X
--------------------------------
VITREOUS GLASS INC. ("VCI")
BULLETIN TYPE: Declaration of Dividend
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
The Issuer has declared the following dividend:
Dividend per Share: $0.06
Payable Date: November 17, 2008
Record Date: November 3, 2008
Ex-distribution Date: October 30, 2008
TSX-X
--------------------------------
>>
SOURCE: TSX Venture Exchange
Market Information Services at 1-888-873-8392, or email: information@venture.com
Tags: acquisition aerospace alberta british columbia canada capitalization corporate debt diamond dividend energy equity exercise exploration family finance gold industrial investment market mining montreal note ontario policy principe Private Placement property real estate research securities security technology
Companies: TSX Group Inc (X)
TSX Venture Exchange Daily Bulletins for October 20, 2008 - Zibb.com
VANCOUVER, BRITISH COLUMBIA, Oct 20, 2008 (Marketwire via COMTEX) --
08/10/20 - TSX Venture Exchange Daily Bulletins
TSX VENTURE COMPANIES
BULLETIN TYPE: Notice to Issuers
BULLETIN DATE: October 20, 2008
Re: Restated Deal Structure and Founder Shares Guidelines
Background
The TSX Venture Exchange (the "Exchange"), in a bulletin published on
December 11, 2007, set out capital structure guidelines for non-CPC
issuers having issued, prior to listing, securities to principals or third
parties for nominal consideration (the "Deal Structure and Founder Shares
Guidelines"). The Exchange may vary these guidelines from time to time, at
the election of the Exchange, in response to general market conditions.
Founder Shares Guidelines which are varied will be restated with
amendments underlined for issuer ease of reference. This bulletin is the
first restated and amended Deal Structure and Founder Shares Guidelines
and supersedes those guidelines published on December 11, 2007. The
purpose of the amendments in these restated and amended guidelines is to
reduce the threshold of an acceptable financing from $10 million to $5
million and to clarify further what is considered by the Exchange to be an
acceptable supporting valuation.
Amendments to Policy
Effective Date
The principles underlying the guidelines set out in this bulletin will be
contained in an amended Exchange Policy 2.1 which the Exchange expects to
issue in its next revision. The information set out in this bulletin
should be used as additional guidance by market participants in
determining whether the capital structure of an issuer will be acceptable
to the Exchange. The concepts set out in this bulletin will be applied by
the Exchange to new listing submissions (including listing submissions
involving IPOs, RTOs or QTs) effective from the date of this bulletin.
Exchange staff will continue to work with market participants to ensure
their deal structures are acceptable and encourage issuers to pre-file
their submissions accordingly. The contents of this bulletin do not
otherwise affect any existing listing requirements contained in Exchange
policies.
General Concept
The Exchange will not object to certain transactions where the amount of
"Founder Shares", as defined below, equals, or falls below, a determined
threshold.
Founder Shares
Founder Shares means any security issued, or proposed to be issued, to:
(i) any person for less than $0.05 per security;
(ii) a party related to the issuer for the purchase of an asset which
cannot be acceptably valued under sections 4.2(a), (b), (c), (d), (e),
(f), (g) or (i) of Exchange Policy 5.4;
(iii) a principal to settle a debt or obligation for less than the last
price per security which the security was issued for or at a price per
security which the Exchange does not consider reasonable given the
circumstances; or
(iv) a principal for the primary purpose of increasing that principal's
interest in the issuer without a corresponding tangible benefit to the
issuer.
The Exchange will consider the number of Founder Shares in the aggregate
in determining whether a transaction structure is acceptable under this
bulletin and the amended policy. In addition, the final determination on
whether a person is or is not a principal or a party related to the issuer
will be that of the Exchange, using its discretion and based upon the
particular facts of the submission and the resulting interest of a
security holder in the issuer after giving effect to the transaction. In
exercising its discretion, the Exchange may deem certain securities, which
have been or are proposed to be issued, and which may not technically be
captured under the "Founder Shares" definition noted above, to be,
nonetheless, Founder Shares.
Allowable Transactions
The Exchange will not object to:
(i) a transaction which otherwise satisfies applicable existing listing
requirements and under which the issuer has issued, or proposes to issue,
Founder Shares, which, cumulatively (and with Founder Shares being
calculated on a fully diluted basis), represent, or would represent no
more than 15% of the issuers' issued and outstanding securities at the
time of listing; or
(ii) a transaction which otherwise satisfies applicable listing
requirements and under which an issuer has issued, or proposes to issue,
Founder Shares which, cumulatively (and with Founder Shares being
calculated on a fully diluted basis), represent, or would represent, in
excess 15% of the issuer's issued and outstanding securities at the time
of listing, provided the issuer also completes an acceptable financing
concurrent with the listing.
The Exchange will consider an acceptable financing to be any equity
financing which:
(A) raises gross proceeds of no less than $5,000,000, of which no less
than 75% has been subscribed for by arm's length parties; or
(B) results in the issuance of no less than 50% of the issued and
outstanding securities of issuer at the time of listing, of which no less
than 75% has been subscribed for by arm's length parties.
Application
As noted above, guidance under this bulletin, and the provisions of the
amended policy, will apply to all new listing submissions effective today.
However, in the case of industrial, technology or research & development
issuers, the Exchange may be more flexible in its application of the
Founder Shares definition. For these issuers, the Exchange may dispense
with the requirement of an acceptable supporting valuation or otherwise
apply flexibility in its interpretation of these guidelines if the person
or persons to whom those securities have been issued has or have clearly
contributed a tangible benefit to the issuer over time. The Exchange
encourages all issuers to meet with Exchange staff prior to making a
listing submission if they have further questions regarding their capital
structure.
If you have questions about these changes, please contact:
In British Columbia: Andrew Hancharyk, Phone: 604-602-6982, Fax: 604-844-
7502
In Alberta: Peter Varsanyi, Phone: 403-218-2860, Fax: 403-234-4211
In Ontario: Tim Babcock, Phone: 416-365-2202, Fax: 416-365-2224
In Quebec: Sylvain Martel, Phone: 514-788-2411, Fax: 514-788-2421
TYPE DE BULLETIN : Avis aux emetteurs
DATE DU BULLETIN : Le 20 octobre 2008
Objet : Version modifiee des lignes directrices sur la structure
d'operation et les actions de fondateur
Contexte
Dans un bulletin publie le 11 decembre 2007, la Bourse de croissance TSX
(la " Bourse ") presentait des lignes directrices sur la structure du
capital a l'intention des emetteurs, autres que les SCD, ayant emis avant
leur inscription des titres a des principaux interesses ou a des tiers
pour une contrepartie symbolique. La Bourse peut modifier ces lignes
directrices a son gre pour tenir compte de la conjoncture du marche. La
version modifiee des lignes directrices sur les actions de fondateur sera
publiee avec les modifications soulignees pour en faciliter la
consultation par les emetteurs. Le present bulletin constitue la premiere
version modifiee des lignes directrices sur la structure d'operation et
les actions de fondateur et remplace les lignes directrices du 11 decembre
2007. Les modifications visent a faire passer le seuil d'un financement
acceptable de 10 millions de dollars a 5 millions de dollars, et a
clarifier ce que la Bourse considere comme une attribution de valeur
acceptable.
Modification de la politique
Date d'effet
Les principes sur lesquels reposent les lignes directrices qui sont
enoncees dans le present bulletin seront integres dans la Politique 2.1
modifiee que la Bourse prevoit publier au moment de la prochaine mise a
jour. L'information contenue dans le present bulletin servira
d'indications supplementaires aux participants du marche qui doivent
determiner si la structure du capital d'un emetteur sera jugee acceptable
par la Bourse. La Bourse appliquera les principes dont il est question ici
aux demandes de nouvelles inscriptions (y compris celles qui sont
presentees dans le cadre d'un premier appel public a l'epargne, d'une
prise de controle inversee ou d'une operation admissible) presentees a
partir de la date du present bulletin. Le personnel de la Bourse
continuera de travailler avec les participants du marche pour veiller a ce
que la structure de leur operation soit acceptable et incitera les
emetteurs a deposer au prealable leur demande. Le contenu du present
bulletin ne modifie aucune des autres exigences d'inscription que
contiennent les politiques en vigueur de la Bourse.
Principe general
La Bourse ne s'opposera pas a certaines operations si le nombre d'"
actions de fondateur ", au sens attribue a ce terme ci-apres, est egal ou
inferieur a un seuil determine.
Actions de fondateur
Les actions de fondateur s'entendent de tout titre emis ou dont on
projette l'emission a l'une des personnes suivantes :
(i) toute personne, a un prix inferieur a 0,05 $ l'action;
(ii) une personne reliee, dans le cadre de l'achat d'un actif auquel on ne
peut attribuer une valeur de facon acceptable conformement aux alineas
4.2a), b), c), d), e), f), g) ou i) de la Politique 5.4 de la Bourse;
(iii) un principal interesse, en reglement d'une dette ou d'une
obligation, a un prix inferieur au dernier prix auquel le titre a ete emis
ou a un prix que la Bourse considere comme deraisonnable dans les
circonstances;
(iv) un principal interesse, en vue principalement d'augmenter la
participation de ce dernier dans l'emetteur, sans que l'emetteur en tire
concretement un avantage reciproque.
La Bourse tiendra compte du nombre global d'actions de fondateur pour
determiner si la structure d'une operation est acceptable aux termes du
present bulletin et de la politique modifiee. De plus, la Bourse decidera
en definitive si une personne est ou non un principal interesse ou une
personne reliee, en usant de son pouvoir discretionnaire et en se fondant
sur les faits de la demande et sur la participation que la personne aura
dans l'emetteur apres l'operation. Dans l'exercice de son pouvoir
discretionnaire, la Bourse pourra neanmoins considerer comme des actions
de fondateur certains titres emis ou dont on projette l'emission qui ne
sont pas en principe compris dans la definition d'" actions de fondateur "
donnee ci-dessus.
Operations permises
La Bourse ne s'opposera pas aux operations suivantes :
(i) l'operation qui repond par ailleurs aux exigences d'inscription en
vigueur applicables et dans le cadre de laquelle l'emetteur a emis ou
projette d'emettre des actions de fondateur qui representent ou
representeraient dans l'ensemble (le nombre d'actions de fondateur etant
calcule apres dilution) au plus 15 % de ses titres emis et en circulation
au moment de l'inscription;
(ii) l'operation qui repond par ailleurs aux exigences d'inscription
applicables et dans le cadre de laquelle l'emetteur a emis ou projette
d'emettre des actions de fondateur qui representent ou representeraient
dans l'ensemble (le nombre d'actions de fondateur etant calcule apres
dilution) plus de 15 % de ses titres emis et en circulation au moment de
l'inscription, a condition que l'emetteur realise egalement un financement
acceptable simultanement a l'inscription.
La Bourse considerera comme acceptable tout financement par actions qui
repond a l'un des criteres suivants :
A) le produit brut reuni s'eleve a au moins 5 000 000 $, et 75 % au moins
des titres emis ont ete souscrits par des personnes sans lien de
dependance;
B) le nombre de titre emis equivaut a 50 % au moins des titres emis et en
circulation de l'emetteur au moment de l'inscription, et 75 % au moins des
titres emis ont ete souscrits par des personnes sans lien de dependance.
Application
Les indications donnees dans le present bulletin et les dispositions de la
politique modifiee s'appliqueront a toutes les demandes de nouvelles
inscriptions presentees a partir de la date du present bulletin.
Cependant, en ce qui concerne les emetteurs des secteurs de l'industrie,
de la technologie et de la recherche et du developpement, la Bourse
pourrait se montrer plus souple dans l'application de la definition des
actions de fondateur. Elle pourrait dispenser ces emetteurs de
l'obligation de fournir une attribution de valeur acceptable ou par
ailleurs assouplir son interpretation des lignes directrices si la ou les
personnes a qui les titres ont ete emis ont clairement apporte un avantage
concret a l'emetteur au fil du temps. La Bourse demande a tous les
emetteurs qui ont d'autres questions au sujet de leur structure du capital
de rencontrer son personnel avant de deposer une demande d'inscription.
Si vous avez des questions au sujet de ces modifications, veuillez
communiquer avec l'une des personnes suivantes :
En Colombie-Britannique : Andrew Hancharyk, tel. : 604-602-698, telec. :
604-844-7502;
En Alberta : Peter Varsanyi, tel. : 403-218-2860, telec. : 403-234-4211;
En Ontario : Tim Babcock, tel. : 416-365-2202, telec. : 416-365-2224;
Au Quebec : Sylvain Martel, tel. : 514-788-2411, telec. : 514-788-2421.
TSX-X
--------------------------------------------------------------------------
AMADOR GOLD CORP. ("AGX")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation with respect to
the first tranche of a Non-Brokered Private Placement announced September
9, 2008 and October 7, 2008:
Number of Shares: 13,357,500 flow-through shares
2,063,050 non flow-through
Purchase Price: $0.10 per share
Warrants: 15,420,050 share purchase warrants to
purchase 15,420,050 shares
Warrant Exercise Price: $0.15 for a two year period
Number of Placees: 15 placees
Finders' Fees: Research Capital Corp. - $14,456.00
Limited Market Dealership - $80,000
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company
must issue a news release announcing the closing of the private placement
and setting out the expiry dates of the hold period(s). The Company must
also issue a news release if the private placement does not close
promptly.
TSX-X
--------------------------------------------------------------------------
ANIMAS RESOURCES LTD. ("ANI")
BULLETIN TYPE: Property-Asset or Share Purchase Agreement
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation in connection
with an Option Agreement dated October 15, 2008 between the Company and
Mineral Lixivian, S.A. de C.V. (Mayo Ramirez Guitierrez, Efren Rosas
Briones and Samuel Ocan?a Garcia) with respect to the Ophelia and Santa
Gertrudis concessions located in the Santa Teresa mining district, Mexico.
The aggregate consideration is US$422,000 over an 18 month period and
217,000 common shares.
TSX-X
--------------------------------------------------------------------------
ARCHANGEL DIAMOND CORPORATION ("AAD")
BULLETIN TYPE: Halt
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
Effective at the open, October 20, 2008, trading in the shares of the
Company was halted pending an announcement; this regulatory halt is
imposed by Investment Industry Regulatory Organization of Canada, the
Market Regulator of the Exchange pursuant to the provisions of Section
10.9(1) of the Universal Market Integrity Rules.
TSX-X
--------------------------------------------------------------------------
ARCHANGEL DIAMOND CORPORATION ("AAD")
BULLETIN TYPE: Resume Trading
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
Effective at 7:15 a.m. PST, October 20, 2008, shares of the Company
resumed trading, an announcement having been made over Canada News Wire.
TSX-X
--------------------------------------------------------------------------
ATW GOLD CORP. ("ATW")
(formerly ATW Venture Corp. ("ATW"))
BULLETIN TYPE: Name Change
BULLETIN DATE: October 20, 2008
TSX Venture Tier 1 Company
Pursuant to a resolution passed by shareholders October 7, 2008, the
Company has changed its name as follows. There is no consolidation of
capital.
Effective at the opening, October 21, 2008, the common shares of ATW Gold
Corp. will commence trading on TSX Venture Exchange, and the common shares
of ATW Venture Corp. will be delisted. The Company is classified as a
'Mining' company.
Capitalization: Unlimited shares with no par value of
which 60,471,256 shares are issued and
outstanding
Escrow: Nil
Transfer Agent: Computershare Trust Company
Trading Symbol: ATW (unchanged)
CUSIP Number: 002105 10 4 (new)
TSX-X
--------------------------------------------------------------------------
AUSAM ENERGY CORPORATION ("AZE")
BULLETIN TYPE: Warrant Price Amendment
BULLETIN DATE: October 20, 2008
TSX Venture Tier 1 Company
TSX Venture Exchange has consented to the temporary reduction in the
exercise price to US$1.50 of the warrants described below. The reductions
will be in effect from October 20, 2008 to November 18, 2008 (the
'Reduction Period'), following which any unexercised warrants will revert
to their original exercise price. During the Reduction Period only, the
warrants will be exercisable for Units instead of common shares. Each Unit
will consist of one common share and one-half of one share purchase
warrant ('Incentive Warrant'). Each whole Incentive Warrant will
exercisable for one additional common share for a period of five years
from the date of issuance at a price of US$1.50 in the first two years,
US$1.65 in the third year, US$1.82 in the fourth year, or US$2.00 in the
fifth year.
Private Placement #1:
# of Warrants: 3,092,682
Expiry Date of Warrants: February 8, 2012
Original Exercise Price of
Warrants: $3.25
New Exercise Price of Warrants: US$1.50
- These warrants were issued pursuant to a private placement of 30,926,842
shares with 15,463,421 share purchase warrants attached, which was
accepted for filing by the Exchange effective April 10, 2007.
Private Placement #2:
# of Warrants: 1,996,666
Expiry Date of Warrants: February 8, 2012
Original Exercise Price of
Warrants: $3.75
New Exercise Price of Warrants: US$1.50
- These warrants were issued pursuant to a private placement of 19,966,666
First Preferred Shares, Series 2 with 9,983,333 share purchase warrants
attached, which was accepted for filing by the Exchange effective April
10, 2007.
Private Placement #3:
# of Warrants: 125,685
Expiry Date of Warrants: September 7, 2012
Original Exercise Price of
Warrants: $3.25
New Exercise Price of Warrants: US$1.50
- These warrants were issued pursuant to a private placement of 1,256,852
shares with 628,425 share purchase warrants attached, which was accepted
for filing by the Exchange effective April 11, 2008.
Private Placement #4:
# of Warrants: 4,461,099
Expiry Date of Warrants: July 3, 2012
Original Exercise Price of
Warrants: $3.00
New Exercise Price of Warrants: US$1.50
- These warrants were issued pursuant to a private placement of a
convertible debenture in the amount of US$25,000,000 with 22,305,496 share
purchase warrants attached, which was accepted for filing by the Exchange
effective July 11, 2007.
- Note that the private placement information included above reflects the
figures prior to the Company's share consolidation effective September 27,
2007.
TSX-X
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BAYMOUNT INCORPORATED ("BYM")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation with respect to
a Non-Brokered Private Placement announced August 28, 2008:
Number of Shares: 3,100,000 shares
Purchase Price: $0.10 per share
Number of Placees: 3 placees
Insider / Pro Group Participation:
Insider equals Y /
Name ProGroup equals P / # of Shares
F. Helmut Biemann Y 400,000
For further details, please refer to the Company's news release dated
August 28, 2008.
TSX-X
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BTB REAL ESTATE INVESTMENT TRUST ("BTB.UN")
BULLETIN TYPE: Notice of Distribution
BULLETIN DATE: October 20, 2008
TSX Venture Tier 1 Company
The Issuer has declared the following distribution:
Distribution per Trust Unit: $0.01333
Payable Date: November 14, 2008
Record Date: October 31, 2008
Ex-Distribution Date: October 29, 2008
TSX-X
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GENOIL INC. ("GNO")
BULLETIN TYPE: Private Placement-Non-Brokered, Convertible Debenture/s
BULLETIN DATE: October 20, 2008
TSX Venture Tier 1 Company
TSX Venture Exchange has accepted for filing documentation with respect to
a Non-Brokered Private Placement:
Convertible Debenture $1,227,355.84
Conversion Price: Convertible into common shares at a rate
of $0.27 of principal per share until
maturity.
Maturity date: October 6, 2009
Warrants 1,136,442
Each warrant is exercisable for one
common share at a price of $0.41 for a
period of one year from the date of
issuance.
Interest rate: 12 %
Number of Placees: 4 placees
Insider / Pro Group Participation:
Insider equals Y / Principal
Name ProGroup equals P / Amount Warrants
Lifschultz Enterprises Co., LLC Y $834,581.78 772,761
Sidney B. Lifschultz 1992 Y $129,218.66 119,647
Family Trust
David K. Lifschultz Y $131,777.70 122,017
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company
must issue a news release announcing the closing of the private placement
and setting out the expiry dates of the hold period(s).
TSX-X
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GOLD STAR RESOURCES CORP. ("GXX")
BULLETIN TYPE: Warrant Term Extension
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has consented to the extension in the expiry date of
the following warrants:
# of Warrants: 1,550,000
Original Expiry Date of Warrants: November 20, 2008
New Expiry Date of Warrants: November 20, 2009
Exercise Price of Warrants: $0.15
These warrants were issued pursuant to a private placement of 3,070,000
shares with 3,070,000 share purchase warrants attached, which was accepted
for filing by the Exchange effective November 16, 2007.
TSX-X
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MACDONALD MINES EXPLORATION LTD. ("BMK")
BULLETIN TYPE: Property-Asset or Share Purchase Agreement
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation relating to an
option agreement (the "Agreement") dated October 2, 2008, between Shoreham
Resources Ltd. (the "Optionor") and MacDonald Mines Exploration Ltd (the
"Company"). Pursuant to the Agreement, the Company shall have the option
to acquire an undivided 40% interest in the Sachigo Lake Property (the
"Property") (the Company will acquire an undivided 100% interest in the
event Escape Group Inc. does not earn it's 60% interest in the Property
pursuant to its pre-existing option agreement with the Optionor). The
interest in the Property shall be subject to a 2.5% net smelter return
royalty, of which the Company shall have the right to 'buy back' 1% at any
time for the sum of $1,000,000.
In order to earn its interest in the Property, the Company must pay the
Optionor an aggregate of $150,000 within three years, issue 300,000 common
shares within one year, and issue 600,000 common share purchase warrants
(each exercisable into 1 common share at a price of $0.40 for a period of
two years from issuance) within one year.
TSX-X
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PETROGLOBE INC. ("PGB")
BULLETIN TYPE: Property Asset or Share Disposition Agreement
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing a Letter of Intent ("LOI")
between PetroGlobe Inc. (the "Company") and 1427668 Alberta Ltd. (the
"Purchaser"). Pursuant to the LOI, the Company will sell 100% of the
common shares it holds in PetroGlobe (Canada) Ltd. to the Purchaser. In
consideration, the Company will receive $350,000.
TSX-X
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PITCHSTONE EXPLORATION LTD. ("PXP")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 1 Company
TSX Venture Exchange has accepted for filing documentation with respect to
a Non-Brokered Private Placement announced September 26, 2008:
Number of Shares: 2,501,000 flow through shares
Purchase Price: $0.60 per share
Number of Placees: 7 placees
Finders' Fees: $58,800 payable to Dundee Securities
Corporation
$15,000 payable to Toll Cross Securities
Inc.
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company
must issue a news release announcing the closing of the private placement
and setting out the expiry dates of the hold period(s). The Company must
also issue a news release if the private placement does not close
promptly.
TSX-X
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PLATINEX INC. ("PTX")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation with respect to
a Non-Brokered Private Placement (first tranche) announced October 3,
2008:
Number of Shares: 1,583,333 flow-through shares and
2,300,000 non flow-through shares
Purchase Price: $0.15 per flow-through share
$0.125 per non flow-through share
Warrants: 2,300,000 share purchase warrants to
purchase 2,300,000 shares
Warrant Exercise Price: $0.35 for a two year period
Number of Placees: 12 placees
Insider / Pro Group Participation:
Insider equals Y /
Name ProGroup equals P / # of Shares
James Marrelli Y 320,000
Korine Craig Y 200,000
Bruce Reilly Y 300,000
James Trusler Y 480,000
Finder's Fees: $3,000 in cash payable to BMO Nesbitt
Burns Ltee., Montreal, QC.
For further details, please refer to the Company's news release dated
October 3, 2008.
TSX-X
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RADISSON MINING RESOURCES INC. ("RDS")
BULLETIN TYPE: Property-Asset or Share Purchase Amending Agreement
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing the documentation relating to
an amended option agreement, dated October 1, 2008. The amendment relates
to payment terms within the original August 29, 2005 agreement, under
which the Company acquired a property located in the Dryden region of the
province of Ontario.
Under the terms of the amended agreement, the final payment, which was to
consist of 20,000 class A shares of the Company and $20,000 in cash will
instead be made with 220,000 class A shares and $5,000 in cash.
For further information, please refer to the Company's press release dated
October 17, 2008.
RESSOURCES MINIERES RADISSON INC. (" RDS ")
TYPE DE BULLETIN : Modification a une convention d'achat de propriete,
d'actif ou d'actions
DATE DU BULLETIN : Le 20 octobre 2008
Societe du groupe 2 de TSX Croissance
Bourse de croissance TSX a accepte le depot de documents relativement a un
amendement a une convention d'option datee du 1er octobre 2008.
L'amendement concerne les modalites de paiement aux termes de l'entente
originale du 29 aoA"t 2005, selon laquelle la societe a acquis une
propriete situe dans la region Dryden en Ontario.
Aux termes de l'entente amendee, le dernier paiement, qui aurait consiste
en 20 000 actions categorie A de la societe et 20 000 $ en especes,
consistera en 220 000 actions categorie A et 5 000 $ en especes.
Pour plus d'information, veuillez vous referer au communique de presse
emis par la societe le 17 octobre 2008.
TSX-X
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SEDEX MINING CORP. ("SDN")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation with respect to
the first tranche of a Non-Brokered Private Placement announced September
9, 2008:
Number of Shares: 6,666,667 flow through shares
625,000 non-flow through shares
Purchase Price: $0.06 per share
Warrants: 7,291,667 share purchase warrants to
purchase 7,291,667 shares
Warrant Exercise Price: $0.10 for a two year period
Number of Placees: 2 placees
Finder's Fee: $32,000 payable to BMO Nesbitt Burns
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company
must issue a news release announcing the closing of the private placement
and setting out the expiry dates of the hold period(s). The Company must
also issue a news release if the private placement does not close
promptly.
TSX-X
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SILK ROAD RESOURCES LTD. ("SIL")
BULLETIN TYPE: Private Placement-Non-Brokered, Convertible Debenture/s
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation with respect to
a Non-Brokered Private Placement announced July 3, 2008, July 16, 2008 and
August 21, 2008:
Convertible Debenture $500,000
Conversion Price: Convertible into common shares at $1.00
of principal outstanding
Maturity date: July 10, 2011
Interest rate: 7% per annum
Number of Placees: 1 placee
Insider / Pro Group Participation:
Insider equals Y /
Name ProGroup equals P / Principal Amount
Patriarco Holdings Ltd. Y $500,000
(Anthony Patriarco and Nancy Patriarco)
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company
must issue a news release announcing the closing of the private placement
and setting out the expiry dates of the hold period(s). The Company must
also issue a news release if the private placement does not close
promptly.
TSX-X
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SOLID RESOURCES LTD. ("SRW")
BULLETIN TYPE: Shares for Debt
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing the Company's proposal to
issue 300,000 shares at a deemed price of $0.20 to settle outstanding debt
for $60,000.
Number of Creditors: 1 Creditor
Insider / Pro Group Participation:
Insider equals Y / Amount Deemed Price
Creditor Progroup equals P / Owing per Share # of Shares
Kevin Moore Y $60,000 $0.20 300,000
The Company shall issue a news release when the shares are issued and the
debt extinguished.
TSX-X
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SOLID RESOURCES LTD. ("SRW")
BULLETIN TYPE: Shares for Debt
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing the Company's proposal to
issue 551,680 shares at a deemed price of $0.20 to settle outstanding debt
for $100,836.
Number of Creditors: 3 Creditors
Insider / Pro Group Participation:
Insider equals Y / Amount Deemed Price
Creditor Progroup equals P / Owing per Share # of Shares
McKinders Financial Y $74,802 $0.20 424,010
(Harry McKinders)
Leonard Trump Y $15,534 $0.20 77,670
The Company shall issue a news release when the shares are issued and the
debt extinguished.
TSX-X
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TEARLACH RESOURCES LIMITED ("TEA")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for expedited filing documentation with
respect to a Non-Brokered Private Placement announced October 15, 2008:
Number of Shares: 1,000,000 shares
Purchase Price: $0.05 per share
Warrants: 1,000,000 share purchase warrants to
purchase 1,000,000 shares
Warrant Exercise Price: $0.10 for a two year period
Number of Placees: 2 placees
Insider / Pro Group Participation:
Insider equals Y /
Name ProGroup equals P / # of Shares
Richard Pomper P 500,000
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company
must issue a news release announcing the closing of the private placement
and setting out the expiry dates of the hold period(s). The Company must
also issue a news release if the private placement does not close
promptly.
TSX-X
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VAULT MINERALS INC. ("VMI")
BULLETIN TYPE: Property-Asset or Share Purchase Agreement
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation pertaining to
an option agreement (the "Agreement") dated September 24, 2008, between
Vault Minerals Inc. (the "Company") and four arms-length parties
(collectively, the "Optionors"). Pursuant to the Agreement, the Company
shall have the option to acquire a 100% undivided interest in a mining
claim (the "Property") located in Teck Township of Ontario.
As consideration, the Company must pay the Optionors an aggregate of
$27,000, issue 90,000 common shares, and incur a minimum aggregate of
$50,000 in exploration expenditures on the Property within the first two
years. The Company must pay the Optionors a 2% royalty (the "Royalty")
from any production on the Property. Furthermore, the Company has the
option to purchase 50% of the Royalty by making a further aggregate
payment of $1,000,000 to the Optionors.
For further information, please refer to the Company's press release dated
October 9, 2008.
TSX-X
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VAULT MINERALS INC. ("VMI")
BULLETIN TYPE: Property-Asset or Share Purchase Agreement
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation pertaining to
an option agreement (the "Agreement") dated September 24, 2008, between
Vault Minerals Inc. (the "Company") and two arms-length parties
(collectively, the "Optionors"). Pursuant to the Agreement, the Company
shall have the option to acquire a 100% undivided interest in a mining
claim (the "Property") located in Teck Township of Ontario.
As consideration, the Company must pay the Optionors an aggregate of
$8,000, issue 30,000 common shares and incur a minimum of $5,000 in
exploration expenditures on the Property within the first year. The
Company must pay the Optionors a 2% royalty (the "Royalty") from any
production on the Property. Furthermore, the Company has the option to
purchase 50% of the Royalty by making a further aggregate payment of
$1,000,000 to the Optionors.
For further information, please refer to the Company's press release dated
October 9, 2008.
TSX-X
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VENGA AEROSPACE SYSTEMS INC. ("VAV")
BULLETIN TYPE: Private Placement-Non-Brokered
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
TSX Venture Exchange has accepted for filing documentation with respect to
a Non-Brokered Private Placement announced October 10, 2008:
Number of Shares: 10,900,000 shares
Purchase Price: $0.05 per share
Number of Placees: 7 placees
Insider / Pro Group Participation:
Insider equals Y /
Name ProGroup equals P / # of Shares
David Jacob Rotfleisch Y 2,000,000
Pursuant to Corporate Finance Policy 4.1, Section 1.11(d), the Company has
issued a news release announcing the closing of the private placement and
setting out the expiry dates of the hold period(s).
TSX-X
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VITREOUS GLASS INC. ("VCI")
BULLETIN TYPE: Declaration of Dividend
BULLETIN DATE: October 20, 2008
TSX Venture Tier 2 Company
The Issuer has declared the following dividend:
Dividend per Share: $0.06
Payable Date: November 17, 2008
Record Date: November 3, 2008
Ex-distribution Date: October 30, 2008
TSX-X
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SOURCE: TSX Venture Exchange - Daily Bulletins
TSX Venture Exchange Market Services (416) 947-4452 marketdata@tsx.ca
Tags: acquisition aerospace alberta british columbia canada capitalization corporate debt diamond dividend energy equity exercise exploration family finance gold industrial investment market mining montreal note ontario policy principe Private Placement property quebec real estate research securities security technology
Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of
Nov 08, 2008 (FIND, Inc. via COMTEX) --
SUMMARY: The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled "Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300." The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document no later than the effective date of this final rule.
EFFECTIVE DATE: Effective Date: This rule is effective January 9, 2009.
Compliance Dates: Premarket notification submissions (510(k)s) for latex condoms filed on or after the effective date of this rule are expected to comply with the requirement of special controls at the time that the 510(k) is submitted. Latex condoms cleared for marketing on or after the effective date of the rule but submitted in 510(k)s filed before the effective date of the rule are expected to comply with the requirement of special controls on or before March 10, 2009. Latex condoms legally marketed before the effective date of this rule are expected to comply with the requirement of special controls December 10, 2009. Specific information on how the rule will be implemented can be found in section II.B of this document.
FOR FURTHER INFORMATION CONTACT:
Colin M. Pollard, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301- 594-1180.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Statutory Framework
B. Regulatory History of Latex Condoms
C. Overview of Proposed Rule
D. Additional Scientific Information Developed After the Completion of the Proposed Rule and Draft Special Control Guidance
1. FDA Update of Epidemiology
2. Latex Condom Label Comprehension Study
II. Summary of the Final Rule
A. Overview of the Final Rule
B. Implementation Strategy
C. Issues Requiring Special Controls
1. Unintended Pregnancy
2. Transmission of Sexually Transmitted Infections (STIs)
3. Incorrect or Inconsistent Use
III. Comments and FDA's Responses
A. Identification Section of the Classification Regulation
B. Establishment of a Guidance Document as a Special Control
C. FDA's Review of Scientific Information
1. General Comments
2. Slippage and Breakage
3. Risk Reduction
4. Evaluation of Latex Condom Effectiveness
D. Labeling Recommendations
1. General
2. Comprehension
3. Pregnancy
4. STIs
5. Correct and Consistent Use
6. Risk Reduction
7. Directions for Use and Precautions
8. Additional Information
E. Comments in Response to FDA's Specific Requests
1. Human Papillomavirus (HPV)
2. Nonlatex Condoms Without Nonoxynol-9
F. Implementation
IV. Environmental Impact
V. Analysis of Impacts
A. Background
B. Affected Entities and Scope of Effect
C. Costs of Implementation
D. Regulatory Flexibility Analysis
VI. Federalism
VII. Paperwork Reduction Act of 1995
VIII. References
I. Background
In the Federal Register of November 14, 2005 (70 FR 69102), FDA proposed to amend existing classification regulations to designate a labeling guidance document as the special control for condoms made of natural rubber latex (latex condoms), classified under 21 CFR 884.5300, and latex condoms with spermicidal lubricant containing nonoxynol-9 (N-9), classified under [Section] 884.5310 (21 CFR 884.5310). As proposed, the final rule amends [Section] 884.5300 (21 CFR 884.5300) and designates a guidance document containing labeling recommendations as the special control for latex condoms. However, FDA continues to review the comments it received in response to its general and specific requests for comment on latex condoms with spermicidal lubricant and to evaluate the controls appropriate for condoms with spermicidal lubricant ( [Section] 884.5310). Therefore, FDA is not issuing a final rule on that device at this time. *1
*1 On December 19, 2007, FDA published a final rule, codified at 21 CFR 201.66(c)(5)(ii)(H) and 21 CFR 201.325, that requires that labeling of OTC vaginal contraceptive/spermicidal drug products containing N-9 bear the following warnings:
. For vaginal use only
. Not for rectal (anal) use
. Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner
. Do not use if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected, choose another form of birth control.
. When using this product you may get vaginal irritation (burning, itching, or a rash)
. Stop use and ask a doctor if you or your partner get burning, itching, a rash or other irritation of the vagina or penis
Other information in the new labeling includes:
. When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate the risk of catching or spreading HIV, the virus that causes AIDS.
. Studies have raised safety concerns that products containing the spermicide nonoxynol 9 can irritate the vagina and rectum. Sometimes this irritation has no symptoms. This irritation may increase the risk of getting HIV/AIDS from an infected partner.
. You can use nonoxynol 9 for birth control with or without a diaphragm or condom if you have sex with only one partner who is not infected with HIV and who has no other sexual partners or HIV risk factors
. Use a latex condom without nonoxynol 9 if you or your sex partner has HIV/AIDS, multiple sex partners, or other HIV risk factors
. Ask a health professional if you have questions about your best birth control and STD prevention methods.
In the following sections of this preamble, FDA addresses the statutory framework, regulatory history, and scientific information related to latex condoms; summarizes the final rule; and responds to the comments on FDA's designation of special controls for the latex condom.
A. Statutory Framework
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.), as amended, including the Medical Device Amendments of 1976 (the 1976
[Page Number 66523]
amendments) (Public Law 94-295) and the Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-629), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).
FDA refers to devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), as preamendments devices. Under section 513 of the act, FDA classifies these devices after the agency takes the following steps: (1) receives a recommendation from a device classification panel (an FDA advisory committee); (2) publishes the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) publishes a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.
FDA refers to devices that were not in commercial distribution before May 28, 1976, as postamendments devices. Postamendments devices are classified automatically by statute (section 513(f) of the act) into class III without any FDA rulemaking process. These devices remain in class III unless FDA does one of the following: (1) reclassifies the device into class I or II; (2) issues an order classifying the device into class I or II in accordance with section 513(f)(2) of the act; or (3) issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a legally marketed device that has been classified into class I or class II or to a preamendments device of a type that has yet to be initially classified in accordance with section 513(b). The agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and regulations at part 807 (21 CFR part 807).
Under the 1976 amendments, class II devices were defined as devices for which there was insufficient information to show that general controls themselves would provide reasonable assurance of safety and effectiveness, but for which there was sufficient information to establish performance standards to provide such assurance. SMDA broadened the definition of class II devices to mean those devices for which the general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and any other appropriate actions the agency deems necessary (section 513(a)(1)(B) of the act).
B. Regulatory History of Latex Condoms *2
*2 As discussed in the 2005 proposed rule (70 FR 69102 at 69112), the proposal was limited to latex condoms, which represent the vast majority of condoms marketed in the United States. As discussed in the proposal, FDA intends to address condoms made from other materials (natural membrane (skin) or synthetic materials) at a future date.
Prior to enactment of the 1976 amendments, latex condoms were marketed in the United States for both contraception and prophylaxis, i.e., reducing the risk of sexually transmitted infections (STIs). *3 As a preamendments device, the latex condom was classified along with hundreds of other devices during FDA's original classification proceedings. Based primarily on the recommendations of experts on the Obstetrics and Gynecology Device Classification Panel, FDA classified latex condoms into class II by regulation published in the Federal Register of February 26, 1980 (45 FR 12710). Condoms were identified as "* * * a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of venereal disease) * * *" ( [Section] 884.5300). This classification regulation does not include condoms with spermicidal lubricant, which are postamendments devices classified under [Section] 884.5300.
*3 With the exception of a reference to the 2005 proposed replacement of "venereal disease" with "sexually transmitted disease," FDA is using "sexually transmitted infection" or "STI" instead of "sexually transmitted disease" or "STD" in the final rule and special controls guidance document. This is discussed in more detail at section III.
At the time that latex condoms were classified into class II, the statutory definition of that class contemplated the establishment of mandatory performance standards for all class II devices, in accordance with section 514(b) of the act (21 U.S.C. 360d(b)). Because of the complex process associated with issuing mandatory performance standards, the agency did not establish a performance standard for condoms or virtually any other class II device before the SMDA in 1990 provided additional options for special controls for class II devices. This rulemaking will for the first time establish a special control for latex condoms.
Latex condoms are also subject to the requirement of premarket notification, a general control requiring a determination of substantial equivalence before they may be marketed, and other general controls, including good manufacturing practices (quality system regulation), registration and listing, adverse event reporting, and the prohibitions on adulteration and misbranding. This device is also subject to labeling requirements applicable to all devices, including a statement of principal intended action(s) and adequate directions for use as described in part 801 (21 CFR part 801).
In addition to the general labeling requirements, latex condoms are subject to specific labeling requirements addressing expiration dating and latex sensitivity (21 CFR 801.435 and 801.437). FDA established expiration dating requirements in response to shelf life studies showing that important latex condom properties can change over time. The expiration dating regulation addresses the risk of latex condom deterioration due to product aging and helps ensure that consumers have information regarding the safe use of latex condoms (62 FR 50501, September 26, 1997). The latex sensitivity labeling requirements were added in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber (62 FR 51021 at 51029, September 30, 1997).
In addition to the history of action regarding latex condoms undertaken under the act, on December 21, 2000, Congress enacted Public Law 106-554, which required that FDA "reexamine existing condom labels" and "determine whether the labels are medically accurate regarding the overall effectiveness or lack of effectiveness of condoms in preventing sexually transmitted diseases, including [human papillomavirus]." In this review, FDA considered the following:
. Physical properties of condoms
. Condom slippage and breakage during actual use
. Plausibility for STI-risk reduction attributable to condoms
. Evaluations of condom effectiveness against STIs by other Federal agencies, and
. Clinical studies of condoms' protection against STIs published in peer- reviewed journals.
[Page Number 66524]
As a result of this review of scientific information and of existing latex condom labeling, FDA concluded that existing latex condom labeling was medically accurate in presenting the conclusion that, as an overall matter, condoms are effective in reducing the risk of STIs. To help consumers make appropriate choices for their particular needs, and therefore to ensure the safe and effective use of condoms, FDA proposed to establish a labeling special control to address some additional, more nuanced information about condoms and STIs, as well as to provide information about contraception, and about appropriate directions and precautions for use of latex condoms. The present rulemaking grew out of that initiative.
C. Overview of Proposed Rule
In the Federal Register of November 14, 2005 (70 FR 69102), FDA issued a proposed rule to amend the classification regulations for condoms ([Subsection] 884.5300 and 884.5310). The proposed regulatory changes were intended to help ensure that latex condoms were used safely and effectively by providing labeling conveying a concise, accurate message that neither exaggerated the degree of protection provided by latex condoms, nor undervalued overall STI-risk reduction provided by latex condom use.
FDA proposed to amend the identification section of the regulations to change the wording "venereal disease" to "sexually transmitted diseases." FDA also proposed to add classification sections to each of the regulations, segregating the subset of condoms in each classification that were made of latex. Finally, FDA proposed to designate as a special control a guidance document with labeling recommendations for latex condoms, because the agency believed that this control, together with general controls, could reasonably assure the safety and effectiveness of these devices. The draft special controls guidance recommended labeling to inform consumers about the extent of protection provided by latex condoms against unintended pregnancy and against STIs, including labeling that informed consumers that STIs can be transmitted in various ways, including transmission to or from the penis and transmission by other types of sexual contact. The draft guidance recommended that labeling explain that latex condoms can reduce the risk of STIs, such as gonorrhea and chlamydia, that are spread to or from the penis by direct contact with the vagina and genital fluids. It further recommended labeling that indicated that some STIs, such as genital herpes and human papillomavirus (HPV), may also be transmitted by contact with infectious skin or mucosa not covered by the latex condom, and that latex condoms provide less protection against these STIs.
FDA proposed to establish the labeling guidance as a special control, by rulemaking, because it meant that manufacturers would be required to address the issues identified in the guidance. Unlike a regular guidance, which imposes no requirements, where a guidance document has been designated as a special control by a rule, manufacturers must address the issues identified in the guidance, either by following the recommendations in the guidance or by some other means that provides equivalent assurances of safety and effectiveness. At the same time, establishing a guidance document as a special control affords greater flexibility than a rule mandating specific labeling language and can facilitate updating labeling as new scientific information becomes available because the special control permits manufacturers to use any labeling that affords equivalent assurances of safety and effectiveness for latex condoms.
In response to FDA's requests for comment, more than one hundred commenters submitted information and comments to the two dockets (one docket for the proposed rule and one docket for the draft special controls guidance document). Comments were submitted by consumers, health professionals, industry, academia, state and Federal government agencies, as well as professional societies and organizations. The comments included different points of interest and concern. Many comments discussed issues involving latex condoms with spermicidal lubricant containing nonoxynol-9, and as discussed earlier, FDA continues to review those comments. In some cases, commenters filed comments to the dockets for both the rule and for the guidance; in other cases, comments were filed in only one docket. Because of the intertwined nature of the proposed rule and guidance and because of the significant overlap in comments, FDA considered all comments in preparing both the final rule and the intended final special control guidance document. *4
*4 The term "intended final special control guidance document" refers to the version of the guidance that is currently available for reference only at http://www.fda.gov/cdrh/comp/guidance/1548ref.html, pending approval under the Paperwork Reduction Act (the PRA). (See Section VII.)
D. Additional Scientific Information Developed After the Completion of the Proposed Rule and Draft Special Control Guidance
1. FDA Update of Epidemiology
In developing the 2005 proposed rule and draft guidance, to assess the overall effectiveness of latex condoms in preventing transmission of STIs, FDA evaluated a variety of scientific evidence and information about condoms and STIs. In particular, FDA considered the physical properties of a condom, which make it capable of acting as a barrier to the pathogens that cause STIs; evidence regarding condom slippage and breakage during actual use; plausibility for STI-risk reduction attributable to condoms, which draws on information about the different routes of transmission of different STIs; and evidence from good quality epidemiological studies published in peer-reviewed journals evaluating condoms and STI-risk reduction, including evaluations of condom effectiveness against STIs by other Federal agencies.
FDA's evaluation divided common STIs into two groups in relation to their usual routes of sexual transmission. FDA identified as Group I those STIs that are sexually transmitted solely either to or from the head of the penis, an area that is covered when a latex condom is used. Group I STIs include HIV/Acquired Immune Deficiency Syndrome (AIDS), gonorrhea, chlamydia, trichomoniasis, *5 and hepatitis B virus (HBV). FDA identified as Group II those STIs that can be transmitted not only through contact with the head of the penis, but also through contact with infected skin outside the area that is covered when a latex condom is used. Group II STIs include HPV, herpes simplex virus (HSV), syphilis, and chancroid. Considering the means of transmission of STIs and the extensive information on the physical characteristics and performance of condoms, as well as the specific clinical data available, FDA concluded that there was strong support for the conclusion that latex condoms reduce the overall risk of transmission
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of STIs. FDA also concluded that the degree of risk reduction for different types of STIs varies with their routes of transmission.
*5 FDA's 2005 proposed rule identified trichomoniasis as a group I STI based on its route of transmission but did not consider any significant new information regarding trichomoniasis because none existed at that time. Neither the prior labeling recommendations nor the draft special control guidance recommended making specific claims for condom effectiveness against trichomoniasis. In formulating this final rule and special control guidance document, FDA also has found no new information about condom effectiveness against this specific pathogen, and does not include specific recommendations for labeling to address it.
As discussed in section III.C, FDA's scientific conclusions were generally supported by the public comments. In preparing this final rule, moreover, FDA ensured that its scientific basis remains sound. Using the same approach as in 2005, analyzing systematic reviews *6 and, when those were not available, analyzing individual clinical studies for STIs, FDA reviewed more recent epidemiological studies and analyses published in peer-reviewed publications from December 2004, the cut-off date for studies considered in developing the proposed rule, through April 30, 2008. Consistent with its findings in 2005, FDA confirmed that latex condoms provide effective protection against all STIs evaluated. FDA findings from its updated review are described in more detail next.
*6 As stated in the proposed rule (70 FR 69102 at 69107), a systematic review means a review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research and to collect and analyze data from studies that are included with the review.
Group I STIs
In the 2005 proposal, FDA concluded that latex condoms, when used correctly and consistently, are effective in reducing the risk of transmission of Group I STIs (70 FR 69102 at 69108). No new data undermine this conclusion and some new studies of particular Group I STIs provide additional support for it. Therefore, FDA's conclusion related to the Group I STIs continues to be that latex condoms when used correctly and consistently are effective in reducing the risk of transmission of group I STIs.
HIV
Well-designed studies evaluated prior to the proposed rule show the effect of consistent condom use on reducing the risk of HIV infection (70 FR 69102 at 69107 to 69108). One well-designed study conducted a meta-analysis (where results of all studies selected are pooled and analyzed) of studies of HIV- discordant subjects (where HIV status is known at the outset of the study, and an uninfected partner has sex with an infected partner) and found that condoms were 90 to 95 percent effective in reducing the incidence of new infections when used consistently. Another study was a systematic review of longitudinal studies and found that consistent use of condoms results in at least an 80 percent reduction in HIV incidence.
No new systematic reviews of condom effectiveness in reducing the risk of HIV infection have been published since the cut-off for studies considered in formulating FDA's proposed rule. On the basis described in the proposed rule, FDA's conclusion remains that consistent and correct use of latex condoms is highly effective in reducing the risk of HIV infection.
Gonorrhea and Chlamydia
Consistent with the FDA conclusions presented in 2005 (70 FR 69102 at 69108), one systematic review presented in 2006 demonstrated that consistent and correct use of condoms reduces risk of both gonorrhea and chlamydia in men and women (Ref. 9).
Hepatitis B Virus (HBV)
As was the case when FDA published its proposed rule, FDA is aware of no systematic reviews of condom effectiveness against HBV infection. Nor were any new epidemiological studies of condom use and HBV infection published during the period of FDA's review for preparation of this final rule. As discussed in the 2005 proposal (70 FR 69102 at 69108), one cross-sectional study showed that correct and consistent condom use was significantly associated with lower prevalence of HBV.
Group II STIs
In the 2005 proposal, FDA concluded that latex condoms, when used correctly and consistently, are effective in reducing the risk of transmission of group II STIs. Studies published since December 2004 support, and in the case of HPV, provide additional evidence for, this conclusion, as discussed below.
HPV
No new systematic reviews of condoms and HPV infection have been published since December 2004. At the time of the 2005 proposed rule, the clinical data regarding the effect of condom use on reducing the risk of infection with HPV was limited, but two systematic reviews supported the conclusion that correct and consistent use of latex condoms can reduce the rates of genital warts and cervical cancer, the main diseases associated with HPV infection (70 FR 69102 at 69108).
Since December 2004, several individual studies have addressed condom use and HPV infection, not only the incidence of HPV-related disease. Of particular note, a longitudinal study of the association of condom use and risk of genital HPV infection found that women who reported consistent condom use for the eight months prior to HPV testing were less likely to acquire a first-time infection of HPV and that women who reported 100 percent condom use in the prior eight months had no cervical squamous intraepithelial lesions detected on their Pap tests (Ref. 10) (hereinafter referred to as "2006 Winer et al. study"). Another study published since the cut-off for the 2005 proposed rule found a higher prevalence of HPV in women who did not use condoms (Ref. 4). Yet another study published since the 2005 proposed rule demonstrated an association between prolonged HPV infection and less consistent condom use (Ref. 7). These newer studies now support the conclusion that condom use not only reduces the risk of genital warts and cervical cancer, it also reduces the risk of HPV infection itself.
Genital Herpes Simplex Virus (HSV)
No new systematic reviews of condoms and HSV infection have been published since December 2004. FDA's 2005 conclusions about latex condom effectiveness were based on the 2002 systematic review showing that condom use reduced the risk of HSV-2 infection for women (70 FR 69102 at 69108). A more recent prospective study showed effectiveness of condom use in reducing the risk of HSV infection in men and replicated effectiveness in women (Ref. 8), supporting the findings of the 2002 systematic review and FDA's 2005 conclusions.
Syphilis
As was the case when FDA published its proposed rule, FDA is not aware of any systematic reviews of condom effectiveness against syphilis infection. FDA's 2005 conclusions about latex condom effectiveness were based primarily on the data from two prospective studies, discussed in the preamble to the proposed rule (70 FR 69102 at 69108), that showed condom use provided significant protection against syphilis. More recently, one study evaluated risks of STIs, including syphilis, in female sex workers and found that failure to use a condom was associated with an increased risk of syphilis (Ref. 6). This information continues to support the conclusion made in the 2005 proposal that correct and consistent latex condom use reduces the risk of syphilis.
Chancroid
Chancroid infection is extremely rare in the United States. In 2006, only 33
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new cases were reported in the United States. (Ref. 1). As in 2005, when FDA published its proposed rule, FDA knows of no systematic review of condom effectiveness against this STI. No new epidemiological studies of condom use and chancroid infection have been identified. Therefore, FDA's conclusions about latex condom effectiveness toward chancroid remain based on the study discussed in the 2005 proposal that reported that condom use was associated with a significantly reduced risk of genital ulcer disease (presumed to be chancroid) among prostitutes in Kenya (70 FR 69102 at 69108).
In summary, FDA believes that conclusions from the additional studies published in peer-reviewed publications from December 2004 through April 30, 2008, are consistent with FDA's 2005 conclusions about latex condom effectiveness. Newer evidence, such as the systematic review of the effect of condom use on transmission of gonorrhea and chlamydia infections (Ref. 9) and the recent epidemiological studies showing that condom use reduced HPV infection (Refs. 7 and 10), replicate or strengthen the basis for these conclusions.
2. Latex Condom Label Comprehension Study
As described in more detail below, many commenters expressed concern that FDA's proposed language for latex condom labeling was confusing, especially in its efforts to describe two tiers of protection afforded by condoms against STIs. These comments expressed serious concerns that FDA's latex condom labeling proposal was overly complex and would ultimately be misunderstood by the consumer. Many argued that this same confusion and misunderstanding would lead to unmerited negative impressions of latex condoms and--ultimately--to an unfounded decrease in latex condom use. One commenter also submitted a study it had conducted of consumer comprehension of the labeling proposed in the draft guidance, the results of which supported the comments that this labeling was not well understood. (This comment and study are discussed in section III of this document, where FDA d